<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/NCT02977780</url>
  </required_header>
  <id_info>
    <org_study_id>16-443</org_study_id>
    <nct_id>NCT02977780</nct_id>
  </id_info>
  <brief_title>INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)</brief_title>
  <official_title>INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patrick Wen, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Puma Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Accelerate Brain Cancer Cure</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quadriga Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 research study is studying several investigational drugs as a possible treatment for&#xD;
      Glioblastoma (GBM).&#xD;
&#xD;
      The drugs involved in this study are :&#xD;
&#xD;
        -  Abemaciclib&#xD;
&#xD;
        -  Temozolomide (temodar)&#xD;
&#xD;
        -  Neratinib&#xD;
&#xD;
        -  CC115&#xD;
&#xD;
        -  QBS10072S&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational drug to learn whether the study drug works in&#xD;
      treating a specific disease. &quot;Investigational&quot; means that the drug is being studied.&#xD;
&#xD;
      In this research study, the investigators are looking to compare the effects, good and bad,&#xD;
      of the standard of care with the three investigational agent sub-studies Abemaciclib,&#xD;
      Neratinib, CC115 to help people with Glioblastoma including the specific molecular changes in&#xD;
      the genes and proteins.&#xD;
&#xD;
      The FDA has approved Temozolomide (temodar) as a treatment for this disease, however the FDA&#xD;
      has not approved Abemaciclib, CC115, Neratinib, QBS10072S for any diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival in Experimental Arms Compared with Standard Therapy</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>2 years</time_frame>
    <description>Safety will be assessed by quantifying the toxicities and grades experienced by subjects, including serious adverse events (SAEs). The following will also be measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival Among Experimental Arms And Biomarker Groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Among Experimental Arms And Biomarker Groups</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Temozolomide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily Radiation for a maximum of 49 days.&#xD;
Temozolomide will be administered orally on a daily dosing schedule&#xD;
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy&#xD;
Temozolomide will also be administered post radiation for up to 6 cycles (5 days/cycle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neratinib with Temozolomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily Radiation for a maximum of 49 days.&#xD;
Temozolomide will be administered orally on a daily dosing schedule&#xD;
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy&#xD;
Neratinib will be taken post radiation at a daily oral pre-determine dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QBS10072S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily Radiation for a maximum of 49 days.&#xD;
QBS10072S will be administered on Day 1 of Radiation Treatment&#xD;
QBS10072S will be administered post- radiation for up to 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Temzolomide capsules</description>
    <arm_group_label>Neratinib with Temozolomide</arm_group_label>
    <arm_group_label>Temozolomide</arm_group_label>
    <other_name>Temodar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neratinib</intervention_name>
    <description>Neratinib tablets</description>
    <arm_group_label>Neratinib with Temozolomide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QBS10072S</intervention_name>
    <description>QBS10072S administered intravenously</description>
    <arm_group_label>QBS10072S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have histologically confirmed intracranial glioblastoma or&#xD;
             gliosarcoma following maximum surgical resection. Tumors primarily localized in the&#xD;
             infratentorial compartment will be excluded.&#xD;
&#xD;
          -  Participants may have had prior surgery for glioblastoma or gliosarcoma but no&#xD;
             systemic or radiation therapy.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Karnofsky performance status ≥60&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Leukocytes ≥3,000/mL&#xD;
&#xD;
               -  Absolute neutrophil count ≥1,500/mL&#xD;
&#xD;
               -  Platelets ≥100,000/mL&#xD;
&#xD;
               -  Hemoglobin ≥ 9g/dl&#xD;
&#xD;
               -  Total bilirubin within normal institutional limits (except for participant's with&#xD;
                  Gilbert's disease)&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal&#xD;
&#xD;
               -  Creatinine ≤ institutional upper limit of normal OR&#xD;
&#xD;
               -  Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels&#xD;
                  above institutional normal.&#xD;
&#xD;
               -  Potassium within normal institutional range, or correctable with supplements&#xD;
&#xD;
               -  Serum amylase ≤ 1.5 x institutional upper limit of normal&#xD;
&#xD;
               -  Serum lipase ≤ 1.5 x institutional upper limit of normal&#xD;
&#xD;
               -  INR &lt; 2.0&#xD;
&#xD;
               -  PTT ≤ institutional upper limit of normal, unless receiving therapeutic low&#xD;
                  molecular weight heparin&#xD;
&#xD;
          -  Must be able to swallow pills.&#xD;
&#xD;
          -  Participants must plan to begin radiation therapy 14-42 days after surgical resection.&#xD;
&#xD;
          -  Immunohistochemically negative for IDH1 R132H mutation.&#xD;
&#xD;
          -  Evidence that the tumor MGMT promoter is unmethylated by standard of care assays.&#xD;
&#xD;
          -  Genotyping data available or in process (data must be available at time of initial&#xD;
             registration if randomization probabilities differ across biomarker subgroups as&#xD;
             determined by the DFCI Coordinating Center) to assign biomarker subgroups through&#xD;
             whole exome sequencing, whole genome copy number analysis, or a combination as&#xD;
             described in Section 9.1.&#xD;
&#xD;
          -  MRI with gadolinium should be obtained within 21 days prior to beginning treatment.&#xD;
             Patients without measurable disease are eligible. Participants must be able to undergo&#xD;
             MRIs (CTs are not allowed for response assessment on study).&#xD;
&#xD;
          -  The effects of the experimental agents used in this study on the developing human&#xD;
             fetus are unknown. For this reason and because other therapeutic agents used in this&#xD;
             trial are known to be teratogenic, women of child-bearing potential (women who are not&#xD;
             free from menses for &gt; 2 years, post hysterectomy/oophorectomy, or surgically&#xD;
             sterilized) and men must agree to use adequate contraception (hormonal or barrier&#xD;
             method of birth control; abstinence) prior to study entry and for the duration of&#xD;
             study participation unless otherwise specified in sub-study that the participant is&#xD;
             randomized to. Should a woman become pregnant or suspect she is pregnant while she or&#xD;
             her partner is participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          -  For women of child bearing potential (women who are not free from menses for &gt; 2&#xD;
             years, post hysterectomy/oophorectomy, or surgically sterilized) a negative serum&#xD;
             pregnancy test must be documented prior to initial registration.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will not be eligible if the original diagnosis was a lower grade glioma&#xD;
             and a subsequent histologic diagnosis revealed glioblastoma.&#xD;
&#xD;
          -  Planned major surgery.&#xD;
&#xD;
          -  Participants who are receiving any other investigational agents.&#xD;
&#xD;
          -  Participants who have had any prior cranial radiotherapy.&#xD;
&#xD;
          -  Planned use of Optune™.&#xD;
&#xD;
          -  History of a different malignancy, unless (a) have been disease-free for at least 2&#xD;
             years and are deemed by the investigator to be at low risk for recurrence of that&#xD;
             malignancy, and/or (b) malignancy was cervical cancer in situ, superficial bladder&#xD;
             cancer or basal cell or squamous cell carcinoma of the skin, and malignancy has been&#xD;
             treated. Patients who meet the above listed criteria and are only on preventative&#xD;
             treatment will be deemed eligible.&#xD;
&#xD;
          -  History of intratumoral or peritumoral hemorrhage if deemed significant by the&#xD;
             treating physician.&#xD;
&#xD;
          -  Impaired cardiac function or clinically significant cardiac diseases, including any of&#xD;
             the following:&#xD;
&#xD;
          -  Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart&#xD;
             failure (New York Heart Association functional classification of ≥2), unstable angina,&#xD;
             myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.&#xD;
&#xD;
          -  Known history of congenital QT prolongation or Torsade de pointes (TdP).&#xD;
&#xD;
          -  Complete left bundle branch or bifascicular block.&#xD;
&#xD;
             --QTc interval &gt; 450 ms for men or &gt; 470 ms for women.&#xD;
&#xD;
          -  Persistent or history of clinically meaningful ventricular arrhythmias or atrial&#xD;
             fibrillation.&#xD;
&#xD;
          -  Unstable pectoris or myocardial infarction ≤ 3 months prior to starting study&#xD;
             treatment.&#xD;
&#xD;
          -  Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg).&#xD;
&#xD;
          -  Other clinically significant heart disease such as congestive heart failure requiring&#xD;
             treatment.&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus, or subjects with either of the following:&#xD;
&#xD;
          -  Fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0&#xD;
             mmol/L), or&#xD;
&#xD;
          -  HbA1c ≥ 8%&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, chronic liver disease (e.g., cirrhosis, hepatitis), chronic renal disease,&#xD;
             pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that&#xD;
             would limit compliance with study requirements. Subjects must be free of any&#xD;
             clinically relevant disease (other than glioma) that would, in the treating&#xD;
             investigator's opinion, interfere with the conduct of the study or study evaluations.&#xD;
&#xD;
          -  Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNS&#xD;
             [qualitative] is detected).&#xD;
&#xD;
          -  Known acute or chronic pancreatitis.&#xD;
&#xD;
          -  Participants with active diarrhea ≥ CTCAE grade 2 despite medical management.&#xD;
&#xD;
          -  Active infection requiring antibiotics.&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
&#xD;
          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly&#xD;
             alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea,&#xD;
             vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection).&#xD;
             Participants with unresolved diarrhea ≥ CTCAE grade 2 will be excluded as previously&#xD;
             indicated.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to any of the experimental agents or other agents used in study.&#xD;
&#xD;
          -  Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital,&#xD;
             phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine,&#xD;
             rufinamide, and felbamate. Participant must be off any EIAEDs for at least 7 days&#xD;
             prior to planned start of study treatment. A list of EIAED and other inducers of&#xD;
             CYP3A4 is provided. Among non-EIAED, caution is recommended with use of valproic acid&#xD;
             due to potential for drug interaction.&#xD;
&#xD;
          -  Participants taking a drug known to be strong inhibitors or inducers of isoenzyme&#xD;
             CYP3A. Participant must be off CYP3A inhibitors and inducers for at least 7 days prior&#xD;
             to planned start of study treatment. NOTE: participants must avoid consumption of&#xD;
             Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids,&#xD;
             pummelos and exotic citrus fruits from 7 days prior to planned start of study&#xD;
             treatment and during the entire study treatment period due to potential CYP3A4&#xD;
             interaction.&#xD;
&#xD;
          -  Current use of herbal preparations/medications, including but not limited to: St.&#xD;
             John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA),&#xD;
             yohimbe, saw palmetto, ginseng. Participants should stop using these herbal&#xD;
             medications 7 days prior to planned start of study treatment.&#xD;
&#xD;
          -  Current use of warfarin sodium or any other coumadin-derivative anticoagulant.&#xD;
             Participant must be off Coumadin-derivative anticoagulants for at least 7 days prior&#xD;
             to planned start of study treatment. Low molecular weight heparin and factor Xa&#xD;
             inhibitors are allowed.&#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>Patrick Y Wen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick Y Wen, MD</last_name>
    <phone>617-632-2166</phone>
    <email>patrick_wen@dfci.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lisa Doherty, NP</last_name>
    <phone>617-632-2166</phone>
    <email>lisa_doherty@dfci.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan Drappatz, MD</last_name>
      <phone>412-864-7791</phone>
      <email>drappatzj@upmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lifespan / Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UT MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Schiff, MD</last_name>
      <phone>434-924-5610</phone>
      <email>Ds4jd@virginia.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Patrick Wen, MD</investigator_full_name>
    <investigator_title>Director, Center for Neuro-Oncology</investigator_title>
  </responsible_party>
  <keyword>Glioblastoma</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>Temozolomide</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/NCT02977780
org study id: 16-443
nct id: NCT02977780
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This research study is studying several investigational drugs as a possible treatment for
      Glioblastoma (GBM).

      The drugs involved in this study are :

        -  Abemaciclib

        -  Temozolomide (temodar)

        -  Neratinib

        -  CC115

        -  QBS10072S
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug to learn whether the study drug works in
      treating a specific disease. "Investigational" means that the drug is being studied.

      In this research study, the investigators are looking to compare the effects, good and bad,
      of the standard of care with the three investigational agent sub-studies Abemaciclib,
      Neratinib, CC115 to help people with Glioblastoma including the specific molecular changes in
      the genes and proteins.

      The FDA has approved Temozolomide (temodar) as a treatment for this disease, however the FDA
      has not approved Abemaciclib, CC115, Neratinib, QBS10072S for any diseases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival in Experimental Arms Compared with Standard Therapy
time frame: 2 years
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 2 years
description: Safety will be assessed by quantifying the toxicities and grades experienced by subjects, including serious adverse events (SAEs). The following will also be measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations.
measure: Progression Free Survival Among Experimental Arms And Biomarker Groups
time frame: 2 years
measure: Overall Survival Among Experimental Arms And Biomarker Groups
time frame: 2 years
measure: Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents
time frame: 2 years
arm group label: Temozolomide
arm group type: Active Comparator
description: Daily Radiation for a maximum of 49 days.
Temozolomide will be administered orally on a daily dosing schedule
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy
Temozolomide will also be administered post radiation for up to 6 cycles (5 days/cycle)
arm group label: Neratinib with Temozolomide
arm group type: Experimental
description: Daily Radiation for a maximum of 49 days.
Temozolomide will be administered orally on a daily dosing schedule
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy
Neratinib will be taken post radiation at a daily oral pre-determine dose
arm group label: QBS10072S
arm group type: Experimental
description: Daily Radiation for a maximum of 49 days.
QBS10072S will be administered on Day 1 of Radiation Treatment
QBS10072S will be administered post- radiation for up to 6 cycles
intervention type: Drug
intervention name: Temozolomide
description: Temzolomide capsules
arm group label: Neratinib with Temozolomide
arm group label: Temozolomide
other name: Temodar
intervention type: Drug
intervention name: Neratinib
description: Neratinib tablets
arm group label: Neratinib with Temozolomide
intervention type: Drug
intervention name: QBS10072S
description: QBS10072S administered intravenously
arm group label: QBS10072S
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Y Wen, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
last name: Patrick Y Wen, MD
phone: 617-632-2166
email: patrick_wen@dfci.harvard.edu
last name: Lisa Doherty, NP
phone: 617-632-2166
email: lisa_doherty@dfci.harvard.edu
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Patrick Wen, MD
investigator title: Director, Center for Neuro-Oncology
mesh term: Glioblastoma
mesh term: Temozolomide
sharing ipd: No