<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421378</url>
  </required_header>
  <id_info>
    <org_study_id>XPORT-GBM-029</org_study_id>
    <secondary_id>2021-000080-67</secondary_id>
    <nct_id>NCT04421378</nct_id>
  </id_info>
  <brief_title>A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma</brief_title>
  <official_title>A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karyopharm Therapeutics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karyopharm Therapeutics Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for&#xD;
      newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be&#xD;
      conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion)&#xD;
      and a Phase 2 randomized efficacy exploration study and will independently evaluate 3&#xD;
      different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or&#xD;
      with rGBM (Arm C).&#xD;
&#xD;
        -  Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM&#xD;
           participants with uMGMT&#xD;
&#xD;
        -  Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide&#xD;
           (TMZ) (S-TRT) in nGBM participants with&#xD;
           methylated-O6-methylguanine-DNA-methyltransferase (mMGMT)&#xD;
&#xD;
        -  Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if&#xD;
           lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status&#xD;
&#xD;
        -  Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants&#xD;
           regardless of MGMT status&#xD;
&#xD;
        -  Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in&#xD;
           rGBM participants regardless of MGMT status&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Upon further consideration of the existing data and the competitive landscape, Karyopharm&#xD;
    Therapeutics Inc has decided not to pursue the ongoing development of Selinexor in GBM at this&#xD;
    time.&#xD;
  </why_stopped>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">July 3, 2023</completion_date>
  <primary_completion_date type="Actual">July 3, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1a: Maximum Tolerated Dose Per Arm: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0</measure>
    <time_frame>During Cycle 1 of treatment (42 days/cycle) for each participant</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1a: Recommended Phase 2 Dose Per Arm</measure>
    <time_frame>Cycle 1 Day 1 up to 14 days after last dose (42 days/cycle)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1a: Number of Participants with Adverse Events (AEs) with Grade Greater Than or Equal to (&gt;=) 3, Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation</measure>
    <time_frame>Up to 30 days post last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1b: Progressive Free Survival at 3 Months for All Arms</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1b: Overall Survival (OS) for All Arms</measure>
    <time_frame>From date of randomization up to death (Up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Progression-free Survival (PFS) in Arms A and B</measure>
    <time_frame>From date of randomization to the date of disease progression or death (Up to 24 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Overall Survival (OS) for Arm C</measure>
    <time_frame>From date of randomization up to death (Up to 24 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1a: Overall Survival (OS) for Each Arm</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Time to Progression (TTP) for Each Arm</measure>
    <time_frame>From first dose of study treatment until progression or death due to progression (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Progressive Free Survival (PFS) for Each Arm</measure>
    <time_frame>From first dose of study treatment until progression or death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Overall Response Rate (ORR) Based on Modified Response Assessment in Neuro-Oncology (RANO) Criteria in Arm C, D and E</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Disease Control Rate (DCR) Based on Modified Response Assessment in Neuro-Oncology Criteria in Arm C, D and E</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Duration of Response (DOR) in Arm C, D and E</measure>
    <time_frame>From the date of first evidence of objective response until progression (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Maximum Plasma Concentration (Cmax) of Selinexor</measure>
    <time_frame>2, 4, and 6 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Area Under the Concentration-time Curve (AUC) of Selinexor</measure>
    <time_frame>2, 4, and 6 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1a/1b: Apparent Clearance (CL) of Selinexor</measure>
    <time_frame>2, 4, and 6 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Number of Participants with Adverse Events (AEs) with Grade Greater Than or Equal to (&gt;=) 3, Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation</measure>
    <time_frame>Up to 30 days post last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Maximum Tolerated Dose</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Recommended Phase 2 Dose</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression Free Survival Per (PFS) as Assessed by Investigator per Modified Response Assessment in Neuro-Oncology Criteria in Arms A and B</measure>
    <time_frame>From date of randomization to the date of disease progression or death (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Survival for Participants With Newly Diagnosed Glioblastoma Multiforme in Arms A and B</measure>
    <time_frame>From date of randomization to death (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression Free Survival (PFS) as Assessed by Independent Review Committee (IRC) per Modified Response Assessment in Neuro-Oncology Criteria in Arm C</measure>
    <time_frame>From date of randomization to the date of disease progression or death (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression Free Survival (PFS) as Assessed by Investigator per Modified Response Assessment in Neuro-Oncology Criteria in Arm C</measure>
    <time_frame>From date of randomization to the date of disease progression or death (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Response Rate (ORR) as Assessed by IRC in Arm C</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Response Rate (ORR) as Assessed by Investigator in Arm C</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Disease Control Rate (DCR) as Assessed by IRC in Arm C(TEAEs) by Severity Grade ≥3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Disease Control Rate (DCR) as Assessed by Investigator in Arm C</measure>
    <time_frame>From first dose of study treatment until death due to any cause (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Duration of Response (DOR) as Assessed by IRC in Arm C</measure>
    <time_frame>From the date of first evidence of objective response until progression (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Duration of Response (DOR) as Assessed by Investigator in Arm C</measure>
    <time_frame>From the date of first evidence of objective response until progression (Up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression Free Survival at 6 Months (PFS6) as Assessed by IRC in all Arms</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression Free Survival at 6 Months (PFS6) as Assessed by Investigator in all Arms</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Survival Rate at 12 and 24 Months in all Arms</measure>
    <time_frame>12 and 24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) by Grade &gt;=3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation</measure>
    <time_frame>Up to 30 days post last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <arm_group>
    <arm_group_label>Phase 1: Arm A: Selinexor+Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with nGBM uMGMT will receive 60 to 80 milligram (mg) of selinexor oral tablet once weekly (QW) across dose level -1, 1, 2, and 3 in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently will continue at 80 mg QW until progressive disease (PD) during adjuvant therapy period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm A Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants with nGBM uMGMT will receive 75 milligram per meter square (mg/m^2) of temozolomide oral capsule once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 cycles during adjuvant therapy period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with nGBM mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, 2b and 3a and 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg (dose level 2a) or 80 mg (dose level 2b and 3a) of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycle 4 to 8 during adjuvant therapy period. Participants will continue selinexor weekly per dose level assigned until PD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants with nGBM mMGMT will receive 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 during adjuvant therapy period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C: Selinexor+Lomustine/Carmustine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with rGBM uMGMT or mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, and 3 and 90-110 mg/m^2 of lomustine or 150-200 mg/m^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle across dose level -1, 1, 2, 2a, and 3 in a 42-day cycle for all cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C Control: Lomustine/Carmustine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants with rGBM uMGMT or mMGMT will receive 110 mg/m^2 of lomustine or 200 mg/m^2 of Carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle in a 42-day cycle for all cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D: Selinexor+Bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and 10 mg/kg of Bevacizumab intravenous (IV) infusion every 2 weeks (Q2W) in 28-day cycle for all cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm E: Selinexor+TTField</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and will receive scalp application of 200 kilohertz (kHz) of transducer array ≥18 hours/day daily for each cycle in 28 day cycle for all cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral</description>
    <arm_group_label>Arm C: Selinexor+Lomustine/Carmustine</arm_group_label>
    <arm_group_label>Arm D: Selinexor+Bevacizumab</arm_group_label>
    <arm_group_label>Arm E: Selinexor+TTField</arm_group_label>
    <arm_group_label>Phase 1: Arm A: Selinexor+Radiation Therapy</arm_group_label>
    <arm_group_label>Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy</arm_group_label>
    <other_name>KPT-330</other_name>
    <other_name>XPOVIO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide (TMZ)</intervention_name>
    <description>Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral</description>
    <arm_group_label>Arm A Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_label>Arm B Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_label>Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy</arm_group_label>
    <other_name>Temodar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lomustine (CCNU)</intervention_name>
    <description>Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral</description>
    <arm_group_label>Arm C Control: Lomustine/Carmustine</arm_group_label>
    <arm_group_label>Arm C: Selinexor+Lomustine/Carmustine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Standard Fractionated Radiation therapy (RT)</intervention_name>
    <description>Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.</description>
    <arm_group_label>Arm A Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_label>Arm B Control: Temozolomide+Radiation Therapy</arm_group_label>
    <arm_group_label>Phase 1: Arm A: Selinexor+Radiation Therapy</arm_group_label>
    <arm_group_label>Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous</description>
    <arm_group_label>Arm D: Selinexor+Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TTField</intervention_name>
    <description>Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.</description>
    <arm_group_label>Arm E: Selinexor+TTField</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carmustine</intervention_name>
    <description>Dose and Formulation: 150 or 200 mg/m^2; Route of Administration: Intravenous</description>
    <arm_group_label>Arm C Control: Lomustine/Carmustine</arm_group_label>
    <arm_group_label>Arm C: Selinexor+Lomustine/Carmustine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines.&#xD;
&#xD;
          -  Age ≥18 years at the time of informed consent and ≥22 year for Arm E.&#xD;
&#xD;
          -  Pathologically confirmed glioblastoma (including all histological variants;&#xD;
             documentation to be provided) that are newly diagnosed (for Arms A and B) or relapsed&#xD;
             disease (for Arm C, D and E) after 1 to 2 line of systemic therapy (RT ± TMZ or RT ±&#xD;
             TMZ in combination with other drug) (surgical resection of recurrent disease allowed).&#xD;
             For Arms A and B, MGMT status should be available.&#xD;
&#xD;
          -  Prior therapy:&#xD;
&#xD;
               1. Arms A and B: participants who have not received RT or any systemic therapy for&#xD;
                  brain tumor and must be eligible for definitive external beam RT and TMZ&#xD;
&#xD;
               2. Arm C, D and E: participants must have received prior treatment with RT with or&#xD;
                  without TMZ and only 1 prior line of therapy (RT ± TMZ in combination with other&#xD;
                  drug is allowed).&#xD;
&#xD;
          -  Measurable disease according to RANO/modified RANO guidelines is required only for Arm&#xD;
             C, D and E; it is not required for Arms A or B.&#xD;
&#xD;
          -  Participants enrolling into Arms C, D, and E must be on a stable or decreasing dose of&#xD;
             corticosteroids (or none) for at least 5 days prior to the baseline magnetic resonance&#xD;
             imaging (MRI).&#xD;
&#xD;
          -  Karnofsky Performance Score (KPS) ≥70 (for Arms A and B) and 60 (for Arms C, D, and&#xD;
             E).&#xD;
&#xD;
          -  Participants must have adequate organ function ≤2 weeks of study treatment as defined&#xD;
             by the following laboratory criteria:&#xD;
&#xD;
               1. Hematological function ≤7 days prior to Cycle 1 Day 1 (C1 D1): Absolute&#xD;
                  neutrophil count (ANC) ≥1.5*10^9 per Liter (/L); platelet count ≥150*10^9/L; and&#xD;
                  hemoglobin (Hb) ≥10.0 gram per deciliter (g/dL). Transfusion is not allowed&#xD;
                  within 7 days prior to C1 D1&#xD;
&#xD;
               2. Hepatic function: bilirubin ≤2*the upper limit of normal (ULN), alanine&#xD;
                  transaminase (ALT) ≤2.5*ULN, aspartate transaminase (AST) ≤2.5*ULN; unless&#xD;
                  bilirubin elevation is related to Gilbert's Syndrome for which bilirubin must be&#xD;
                  &lt;4*ULN&#xD;
&#xD;
               3. Renal function: calculated (Cockcroft-Gault) or measured creatinine clearance ≥30&#xD;
                  milliliter per minute (mL/min)&#xD;
&#xD;
          -  Female participants of childbearing potential must have a negative serum pregnancy&#xD;
             test at Screening and agree to use highly effective methods of contraception&#xD;
             throughout the study and for 6 months following the last dose of study treatment.&#xD;
&#xD;
          -  Fertile male participants who are sexually active with a female of childbearing&#xD;
             potential must use highly effective methods of contraception throughout the study and&#xD;
             for 6 months following the last dose of study treatment.&#xD;
&#xD;
          -  For Arms A and B: participants must have had surgery and/or biopsy not greater than&#xD;
             [&gt;] 8 weeks prior to initial screening.&#xD;
&#xD;
          -  Participants must consent to provide tumor tissue and blood samples to be used for&#xD;
             future molecular testing for correlative studies.&#xD;
&#xD;
          -  Limited to supratentorial disease for Arm E only.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        - Participants who are receiving any other investigational agents and /or have had prior&#xD;
        therapy including:&#xD;
&#xD;
        For Arms A and B only:&#xD;
&#xD;
          1. Participants who have previously received RT to the brain&#xD;
&#xD;
          2. Participants who received chemotherapy for the treatment of their glioma&#xD;
&#xD;
          3. Participants who are being treated with implanted Gliadel wafers&#xD;
&#xD;
             For Arm C:&#xD;
&#xD;
          4. Prior nitrosoureas&#xD;
&#xD;
             For Arms C, D, and E:&#xD;
&#xD;
          5. &lt;4 weeks from prior TMZ or other chemotherapy, or &lt;4 weeks or 5 half-lives (whichever&#xD;
             is shorter) for investigational agents prior to start of study treatment&#xD;
&#xD;
          6. Prior treatment bevacizumab or other direct Vascular endothelial growth&#xD;
             factor/Vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors. For any&#xD;
             questions of the definition of a direct VEGF/VEGFR inhibitor, consult the study&#xD;
             Medical Monitor&#xD;
&#xD;
          7. Any AE which has not recovered to Grade &lt;=1, or returned to baseline, related to the&#xD;
             previous GBM therapy, except alopecia, and some other Grade 2 AEs that have been&#xD;
             stabilized (upon Medical Monitor approval)&#xD;
&#xD;
               -  Participants who are being treated or plan to be treated during this study with&#xD;
                  TTField for participants in Arms A to D.&#xD;
&#xD;
               -  Major surgery &lt;2 weeks prior to the start of study treatment for Arms A to C and&#xD;
                  E, &lt;4 weeks for Arm D.&#xD;
&#xD;
               -  History of allergic reactions attributed to compounds of similar chemical or&#xD;
                  biological composition to selinexor or other study treatment.&#xD;
&#xD;
               -  Participants must not have significantly diseased or obstructed gastrointestinal&#xD;
                  tract malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow&#xD;
                  oral medication.&#xD;
&#xD;
               -  Participants with coagulation problems and medically significant bleeding in the&#xD;
                  month prior to start of treatment (peptic ulcers, epistaxis, intracranial&#xD;
                  hemorrhage, spontaneous bleeding). Prior history of deep vein thrombosis or&#xD;
                  pulmonary embolism is not exclusionary.&#xD;
&#xD;
               -  Currently pregnant or breastfeeding.&#xD;
&#xD;
               -  For Arms A and B: participants with pre-existing known or suspected radiation&#xD;
                  sensitivity syndromes will be excluded due to potential confounding effect on&#xD;
                  outcome.&#xD;
&#xD;
               -  Any life-threatening illness, active medical condition, organ system dysfunction,&#xD;
                  or serious active psychiatric issue which, in the Investigator's opinion, could&#xD;
                  compromise the participant's safety or the participant's ability to remain&#xD;
                  compliant with study procedures.&#xD;
&#xD;
               -  Uncontrolled (i.e., clinically unstable) infection requiring parenteral&#xD;
                  antibiotics, antivirals, or antifungals within 7 days prior to first dose of&#xD;
                  study treatment; however, prophylactic use of these agents is acceptable even if&#xD;
                  parenteral.&#xD;
&#xD;
               -  Participants with mutated isocitrate dehydrogenase (IDH) should be excluded for&#xD;
                  Phase 2.&#xD;
&#xD;
               -  For participants in Arm C, Forced Vital Capacity (FVC) or Carbon Monoxide&#xD;
                  Diffusing Capacity (DLCO) below 70% of predicted.&#xD;
&#xD;
               -  For Arm E: implanted active electronic medical devices such as programmable&#xD;
                  intraventricular shunts, spinal cord, vagus nerve or deep brain stimulators,&#xD;
                  pacemakers or implantable automatic defibrillators, skull defect (i.e. missing&#xD;
                  bone with no replacement), sensitivity to conductive hydrogels as used in&#xD;
                  electrocardiograms (ECGs), an underlying serious scalp condition that may&#xD;
                  interfere with placement of arrays, or bullet fragments, or documented clinically&#xD;
                  significant arrhythmias.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew B Lassman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California (USC Norris Comprehensive Cancer Center and LAC+USC Medical Center)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital of Miami Cancer Institute, 8900 North Kendall Drive</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Meridian Health, 92 Second Street</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health Systems Hospital Corp.</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital-Northwell Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah - Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington - Alvord Brain Tumor Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital (PMH)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2MG</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nGBM</keyword>
  <keyword>rGBM</keyword>
  <keyword>GBM</keyword>
  <keyword>Temozolomide</keyword>
  <keyword>Lomustine</keyword>
  <keyword>KPT-330</keyword>
  <keyword>XPOVIO</keyword>
  <keyword>Selinexor</keyword>
  <keyword>Newly diagnosed glioblastoma multiforme</keyword>
  <keyword>Recurrent glioblastoma multiforme</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>TTField</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Carmustine</mesh_term>
    <mesh_term>Lomustine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421378
org study id: XPORT-GBM-029
secondary id: 2021-000080-67
nct id: NCT04421378
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for
      newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be
      conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion)
      and a Phase 2 randomized efficacy exploration study and will independently evaluate 3
      different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or
      with rGBM (Arm C).

        -  Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM
           participants with uMGMT

        -  Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide
           (TMZ) (S-TRT) in nGBM participants with
           methylated-O6-methylguanine-DNA-methyltransferase (mMGMT)

        -  Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if
           lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status

        -  Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants
           regardless of MGMT status

        -  Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in
           rGBM participants regardless of MGMT status
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1a: Maximum Tolerated Dose Per Arm: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
time frame: During Cycle 1 of treatment (42 days/cycle) for each participant
measure: Phase 1a: Recommended Phase 2 Dose Per Arm
time frame: Cycle 1 Day 1 up to 14 days after last dose (42 days/cycle)
measure: Phase 1a: Number of Participants with Adverse Events (AEs) with Grade Greater Than or Equal to (>=) 3, Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation
time frame: Up to 30 days post last dose
measure: Phase 1b: Progressive Free Survival at 3 Months for All Arms
time frame: 3 Months
measure: Phase 1b: Overall Survival (OS) for All Arms
time frame: From date of randomization up to death (Up to 24 months)
measure: Phase 2: Progression-free Survival (PFS) in Arms A and B
time frame: From date of randomization to the date of disease progression or death (Up to 24 months)
measure: Phase 2: Overall Survival (OS) for Arm C
time frame: From date of randomization up to death (Up to 24 months)
measure: Phase 1a: Overall Survival (OS) for Each Arm
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 1a/1b: Time to Progression (TTP) for Each Arm
time frame: From first dose of study treatment until progression or death due to progression (Up to 24 months)
measure: Phase 1a/1b: Progressive Free Survival (PFS) for Each Arm
time frame: From first dose of study treatment until progression or death due to any cause (Up to 24 months)
measure: Phase 1a/1b: Overall Response Rate (ORR) Based on Modified Response Assessment in Neuro-Oncology (RANO) Criteria in Arm C, D and E
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 1a/1b: Disease Control Rate (DCR) Based on Modified Response Assessment in Neuro-Oncology Criteria in Arm C, D and E
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 1a/1b: Duration of Response (DOR) in Arm C, D and E
time frame: From the date of first evidence of objective response until progression (Up to 24 months)
measure: Phase 1a/1b: Maximum Plasma Concentration (Cmax) of Selinexor
time frame: 2, 4, and 6 hours post-dose
measure: Phase 1a/1b: Area Under the Concentration-time Curve (AUC) of Selinexor
time frame: 2, 4, and 6 hours post-dose
measure: Phase 1a/1b: Apparent Clearance (CL) of Selinexor
time frame: 2, 4, and 6 hours post-dose
measure: Phase 1b: Number of Participants with Adverse Events (AEs) with Grade Greater Than or Equal to (>=) 3, Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation
time frame: Up to 30 days post last dose
measure: Phase 1b: Maximum Tolerated Dose
time frame: Up to 24 months
measure: Phase 1b: Recommended Phase 2 Dose
time frame: Up to 24 months
measure: Phase 2: Progression Free Survival Per (PFS) as Assessed by Investigator per Modified Response Assessment in Neuro-Oncology Criteria in Arms A and B
time frame: From date of randomization to the date of disease progression or death (Up to 24 months)
measure: Phase 2: Overall Survival for Participants With Newly Diagnosed Glioblastoma Multiforme in Arms A and B
time frame: From date of randomization to death (Up to 24 months)
measure: Phase 2: Progression Free Survival (PFS) as Assessed by Independent Review Committee (IRC) per Modified Response Assessment in Neuro-Oncology Criteria in Arm C
time frame: From date of randomization to the date of disease progression or death (Up to 24 months)
measure: Phase 2: Progression Free Survival (PFS) as Assessed by Investigator per Modified Response Assessment in Neuro-Oncology Criteria in Arm C
time frame: From date of randomization to the date of disease progression or death (Up to 24 months)
measure: Phase 2: Overall Response Rate (ORR) as Assessed by IRC in Arm C
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 2: Overall Response Rate (ORR) as Assessed by Investigator in Arm C
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 2: Disease Control Rate (DCR) as Assessed by IRC in Arm C(TEAEs) by Severity Grade ≥3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 2: Disease Control Rate (DCR) as Assessed by Investigator in Arm C
time frame: From first dose of study treatment until death due to any cause (Up to 24 months)
measure: Phase 2: Duration of Response (DOR) as Assessed by IRC in Arm C
time frame: From the date of first evidence of objective response until progression (Up to 24 months)
measure: Phase 2: Duration of Response (DOR) as Assessed by Investigator in Arm C
time frame: From the date of first evidence of objective response until progression (Up to 24 months)
measure: Phase 2: Progression Free Survival at 6 Months (PFS6) as Assessed by IRC in all Arms
time frame: 6 Months
measure: Phase 2: Progression Free Survival at 6 Months (PFS6) as Assessed by Investigator in all Arms
time frame: 6 Months
measure: Phase 2: Overall Survival Rate at 12 and 24 Months in all Arms
time frame: 12 and 24 Months
measure: Phase 2: Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) by Grade >=3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation
time frame: Up to 30 days post last dose
arm group label: Phase 1: Arm A: Selinexor+Radiation Therapy
arm group type: Experimental
description: Participants with nGBM uMGMT will receive 60 to 80 milligram (mg) of selinexor oral tablet once weekly (QW) across dose level -1, 1, 2, and 3 in combination with 2 Gray (Gy) radiation therapy (RT) daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 80 mg of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2 and subsequently will continue at 80 mg QW until progressive disease (PD) during adjuvant therapy period.
arm group label: Arm A Control: Temozolomide+Radiation Therapy
arm group type: Active Comparator
description: Participants with nGBM uMGMT will receive 75 milligram per meter square (mg/m^2) of temozolomide oral capsule once daily (QD) in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 cycles during adjuvant therapy period.
arm group label: Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy
arm group type: Experimental
description: Participants with nGBM mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, 2b and 3a and 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 60 mg (dose level 2a) or 80 mg (dose level 2b and 3a) of selinexor oral tablet on Day 1 and 15 in a 28-day Cycle 2, followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycle 4 to 8 during adjuvant therapy period. Participants will continue selinexor weekly per dose level assigned until PD.
arm group label: Arm B Control: Temozolomide+Radiation Therapy
arm group type: Active Comparator
description: Participants with nGBM mMGMT will receive 75 mg/m^2 of temozolomide oral capsule QD in combination with 2 Gy RT daily for 5 days per week in a 42-day cycle during Cycle 1 radiation period followed by 150 mg/m^2 (started from Cycle 3) and increase to 200 mg/m^2 as tolerated per Investigator's judgment, daily for 5 days in a 28-day cycle during Cycles 4 to 8 during adjuvant therapy period.
arm group label: Arm C: Selinexor+Lomustine/Carmustine
arm group type: Experimental
description: Participants with rGBM uMGMT or mMGMT will receive 40-80 mg of selinexor oral tablet QW across dose level -1, 1, 2, 2a, and 3 and 90-110 mg/m^2 of lomustine or 150-200 mg/m^2 of carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle across dose level -1, 1, 2, 2a, and 3 in a 42-day cycle for all cycles.
arm group label: Arm C Control: Lomustine/Carmustine
arm group type: Active Comparator
description: Participants with rGBM uMGMT or mMGMT will receive 110 mg/m^2 of lomustine or 200 mg/m^2 of Carmustine (substituted if lomustine is not available) capsule on Day 1 of each cycle in a 42-day cycle for all cycles.
arm group label: Arm D: Selinexor+Bevacizumab
arm group type: Experimental
description: Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and 10 mg/kg of Bevacizumab intravenous (IV) infusion every 2 weeks (Q2W) in 28-day cycle for all cycles.
arm group label: Arm E: Selinexor+TTField
arm group type: Experimental
description: Participants with rGBM will receive 60-80 mg of selinexor oral tablet QW across dose level -1, 1 and will receive scalp application of 200 kilohertz (kHz) of transducer array ≥18 hours/day daily for each cycle in 28 day cycle for all cycles.
intervention type: Drug
intervention name: Selinexor
description: Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral
arm group label: Arm C: Selinexor+Lomustine/Carmustine
arm group label: Arm D: Selinexor+Bevacizumab
arm group label: Arm E: Selinexor+TTField
arm group label: Phase 1: Arm A: Selinexor+Radiation Therapy
arm group label: Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy
other name: KPT-330
other name: XPOVIO
intervention type: Drug
intervention name: Temozolomide (TMZ)
description: Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral
arm group label: Arm A Control: Temozolomide+Radiation Therapy
arm group label: Arm B Control: Temozolomide+Radiation Therapy
arm group label: Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy
other name: Temodar
intervention type: Drug
intervention name: Lomustine (CCNU)
description: Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral
arm group label: Arm C Control: Lomustine/Carmustine
arm group label: Arm C: Selinexor+Lomustine/Carmustine
intervention type: Radiation
intervention name: Standard Fractionated Radiation therapy (RT)
description: Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.
arm group label: Arm A Control: Temozolomide+Radiation Therapy
arm group label: Arm B Control: Temozolomide+Radiation Therapy
arm group label: Phase 1: Arm A: Selinexor+Radiation Therapy
arm group label: Phase 1: Arm B: Selinexor+Temozolomide+Radiation Therapy
intervention type: Drug
intervention name: Bevacizumab
description: Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous
arm group label: Arm D: Selinexor+Bevacizumab
intervention type: Device
intervention name: TTField
description: Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.
arm group label: Arm E: Selinexor+TTField
intervention type: Drug
intervention name: Carmustine
description: Dose and Formulation: 150 or 200 mg/m^2; Route of Administration: Intravenous
arm group label: Arm C Control: Lomustine/Carmustine
arm group label: Arm C: Selinexor+Lomustine/Carmustine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew B Lassman, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Bevacizumab
mesh term: Temozolomide
mesh term: Carmustine
mesh term: Lomustine
sharing ipd: No