<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/NCT03776071</url>
  </required_header>
  <id_info>
    <org_study_id>DB102-01</org_study_id>
    <nct_id>NCT03776071</nct_id>
  </id_info>
  <brief_title>A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Denovo Biopharma LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Denovo Biopharma LLC</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 study will be conducted as a randomized, double-blind, placebo-controlled, multi-center&#xD;
      Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all&#xD;
      eligibility criteria will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 16, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Radiotherapy (RT) plus temozolomide (TMZ) and enzastaurin (ENZ) (Concurrent Phase) followed by enzastaurin alone (Single-Agent Phase), then temozolomide and enzastaurin (Adjuvant Phase)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RT plus TMZ and placebo; placebo; TMZ and placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Radiotherapy (RT) plus temozolomide (TMZ) and placebo followed placebo then by temozolomide and placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzastaurin Hydrochloride</intervention_name>
    <description>mg</description>
    <arm_group_label>RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ</arm_group_label>
    <other_name>Kinenza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>mg</description>
    <arm_group_label>RT plus TMZ and placebo; placebo; TMZ and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>mg/m^2</description>
    <arm_group_label>RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ</arm_group_label>
    <arm_group_label>RT plus TMZ and placebo; placebo; TMZ and placebo</arm_group_label>
    <other_name>Temodar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Gy</description>
    <arm_group_label>RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ</arm_group_label>
    <arm_group_label>RT plus TMZ and placebo; placebo; TMZ and placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
        Patients must meet all the following inclusion criteria to be eligible for enrollment into&#xD;
        the study:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Age ≥ 18 years with life expectancy &gt; 12 weeks&#xD;
&#xD;
          3. Histologically proven, newly diagnosed supratentorial glioblastoma (IDH mutant is&#xD;
             excluded) based on the WHO classification (2016) which includes gliosarcoma (GS);&#xD;
             prior diagnosis of lower grade astrocytoma that has been upgraded to histologically&#xD;
             confirmed glioblastoma is eligible if chemotherapy and radiation therapy&#xD;
             treatment-naïve&#xD;
&#xD;
          4. Randomization must occur within approximately 6 weeks after resection (patients&#xD;
             undergoing biopsy only are excluded from the study)&#xD;
&#xD;
          5. Craniotomy site must be adequately healed, free of drainage or cellulitis and the&#xD;
             underlying cranioplasty must appear intact prior to start of study treatment&#xD;
&#xD;
          6. DGM1 biomarker status (positive or negative) is available prior to randomization&#xD;
&#xD;
          7. Availability of tumor tissue representative of glioblastoma from surgery, and MGMT&#xD;
             promoter methylation status is determined prior to study randomization&#xD;
&#xD;
          8. Karnofsky performance status (KPS) ≥ 70 (Appendix 1)&#xD;
&#xD;
          9. Stable or decreasing corticosteroids within 5 days prior to study treatment start&#xD;
&#xD;
         10. Willing to forego the use of Tumor Treating Fields therapy (Optune®)&#xD;
&#xD;
         11. Adequate organ function within 14 days prior to randomization:&#xD;
&#xD;
             Bone marrow&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;&#xD;
&#xD;
               2. Platelet count ≥ 100 x 109/L;&#xD;
&#xD;
               3. Hemoglobin ≥ 10 g/dL (eligibility level for hemoglobin may be met by transfusion)&#xD;
                  Renal&#xD;
&#xD;
               4. Serum creatinine &lt; 1.5 x upper limit of normal (ULN) or calculated creatinine&#xD;
                  clearance ≥ 60 mL/min as calculated using an appropriately validated prediction&#xD;
                  equation for the estimation of eGFR (eg, Cockcroft-Gault or MDRD method).&#xD;
&#xD;
                  Hepatic&#xD;
&#xD;
               5. Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert&#xD;
                  syndrome;&#xD;
&#xD;
               6. Aspartate and Alanine transaminase (AST/SGOT and ALT/SGPT) ≤ 2.5 x ULN;&#xD;
&#xD;
               7. Alkaline phosphatase (ALP) ≤ 2.5 x ULN&#xD;
&#xD;
         12. Negative serum pregnancy test (for females of childbearing potential) within 7 days&#xD;
             prior to the first study treatment&#xD;
&#xD;
         13. Male and female patients of reproductive potential must agree to use an effective&#xD;
             method of contraception (eg, oral contraceptives, intrauterine device, barrier method)&#xD;
             throughout the study and for at least 3 months after the last dose of study treatment,&#xD;
             or 6 months for female patients in regard to the last dose of temozolomide (TMZ),&#xD;
             whichever is later&#xD;
&#xD;
               -  Men are considered of reproductive potential unless they have undergone a&#xD;
                  vasectomy and confirmed sterile by a post-vasectomy semen analysis&#xD;
&#xD;
               -  Male patients must agree not to donate their semen during treatment with&#xD;
                  temozolomide and for at least 6 months after their last dose of temozolomide&#xD;
&#xD;
               -  Women are considered of reproductive potential unless they have undergone&#xD;
                  hysterectomy and/or surgical sterilization (at least 6 weeks following a&#xD;
                  bilateral oophorectomy, bilateral tubal ligation, or bilateral tubal occlusive&#xD;
                  procedure that has been confirmed in accordance with the device's label), have&#xD;
                  medically confirmed ovarian failure, or achieved postmenopausal status (defined&#xD;
                  as cessation of regular menses for at least 12 consecutive months with no&#xD;
                  alternative pathological or physiological cause; status may be confirmed by&#xD;
                  having a serum follicle-stimulating hormone (FSH) level within the laboratory's&#xD;
                  reference range for postmenopausal women&#xD;
&#xD;
         14. Willing and able to comply with the protocol&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
        Patients with any of the following characteristics/conditions will be excluded from study:&#xD;
&#xD;
          1. Unable to swallow tablets or capsules&#xD;
&#xD;
          2. Pregnant or breastfeeding&#xD;
&#xD;
          3. Prior chemotherapy (including carmustine-containing wafers (Gliadel®), immunotherapy&#xD;
             (including vaccine therapy), or investigational products for GBM or GS (previous&#xD;
             5-aminolevulinic acid (ALA)-mediated photodynamic therapy (PDT) administered prior to&#xD;
             surgery to aid in optimal surgical resection is permitted)&#xD;
&#xD;
          4. Glioblastoma IDH mutant&#xD;
&#xD;
          5. Prior radiation therapy to the brain&#xD;
&#xD;
          6. Unable to discontinue use of enzyme-inducing anti-epileptic drugs (EIAEDs), see&#xD;
             Section 5.1.2.4.1; if previously taking EIAEDs, must have been discontinued ≥ 2 weeks&#xD;
             prior to randomization&#xD;
&#xD;
          7. Use of a strong inducer or moderate or strong inhibitor of CYP3A4 (Appendix 2) within&#xD;
             7 days prior to randomization or expected requirement for use on study therapy&#xD;
&#xD;
          8. Use of warfarin that cannot be stopped prior to the study.&#xD;
&#xD;
          9. Use of any medication that can prolong the QT/QTc interval (Appendix 3) within 7 days&#xD;
             prior to start of study therapy, or plan to use such a medication during the study&#xD;
&#xD;
         10. Active bacterial, fungal or viral infection requiring systemic treatment&#xD;
&#xD;
         11. Personal or family history of abnormal long QT interval, QTc interval &gt; 450 msec&#xD;
             (males) or &gt; 470 msec (females) as read on the printout of the electrocardiogram (ECG)&#xD;
             at screening (recommended that QTc be calculated using Fridericia's correction&#xD;
             formula, QTcF: see Section 7.3.2.2), or a history of unexplained syncope&#xD;
&#xD;
         12. Unstable angina; myocardial infarction or coronary artery bypass graft/percutaneous&#xD;
             stent placement within 6 months of starting study treatment, congestive heart failure&#xD;
             requiring treatment (New York Heart Association [NYHA] Grade ≥2)&#xD;
&#xD;
         13. History of significant cardiac arrhythmia (ventricular tachycardia or fibrillation,&#xD;
             Torsades de Pointe) or second- or third-degree A-V block, symptomatic bradycardia&#xD;
             (unless controlled with a pacemaker)&#xD;
&#xD;
         14. Persistent electrolyte abnormalities such as hypokalemia or hypomagnesemia that do not&#xD;
             respond to treatment&#xD;
&#xD;
         15. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency&#xD;
             syndrome (AIDS)&#xD;
&#xD;
         16. Evidence of chronic hepatitis C infection as indicated by antibody to hepatitis C&#xD;
             virus (HCV) with positive HCV ribonucleic acid (RNA)&#xD;
&#xD;
         17. Evidence of active or chronic hepatitis B infection as indicated by either:&#xD;
&#xD;
             hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb)&#xD;
             positive with hepatitis B virus-deoxyribonucleic acid (HBV-DNA) positive (any&#xD;
             detectable amount is considered positive)&#xD;
&#xD;
         18. Any contraindication to temozolomide listed in the local product label&#xD;
&#xD;
         19. Another malignancy except adequately treated non-melanoma skin cancer; patients who&#xD;
             have had another primary malignancy in the past, but have been disease-free for more&#xD;
             than 5 years, and patients who have had a localized malignancy treated with curative&#xD;
             intent and disease free for more than 2 years are eligible&#xD;
&#xD;
         20. Participation in other studies involving investigational product(s) within 30 days&#xD;
             prior to randomization&#xD;
&#xD;
         21. Other severe acute or chronic medical or psychiatric condition, including recent&#xD;
             (within the past year) or active suicidal ideation or behavior, or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or&#xD;
             investigational product administration or may interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, would make the patient&#xD;
             inappropriate for participation in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center - Duarte</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine Health Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Southern California</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco Helen Diller Family Comprehensive CA Ctr</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Sky Neurology</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital - New Haven</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-1865</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute of Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute - Multidisciplinary Clinic</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Nasseff Neuroscience Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455-4800</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine Center for Advanced Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Meridian Health - JFK Medical Center</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Medical Oncology Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York - Presbyterian - Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Messino Cancer Centers</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599-7055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health - Comprehensive Cancer Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University - The James Cancer Hospital and Solove Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Health Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Medicine - Perelman Center for Advanced Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center - Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI - Tennessee Oncology - Nashville - Centennial</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt - Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Cancer Center - Park St. David's</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston (UT Health)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mays Cancer Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109--1023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency - Abbotsford</name>
      <address>
        <city>Abbotsford</city>
        <state>British Columbia</state>
        <zip>V2S OC2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency - Victoria</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 6V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Center</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of USTC - Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tian Tan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanbo Brain Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100093</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Second People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xian</city>
        <state>Shaanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Huanhu Hospital</name>
      <address>
        <city>Jinnan</city>
        <state>Tianjin</state>
        <zip>300350</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>China</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT03776071
org study id: DB102-01
nct id: NCT03776071
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center
      Phase 3 study. Approximately 300 subjects with newly diagnosed glioblastoma who meet all
      eligibility criteria will be enrolled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Survival
time frame: Up to 3 years
arm group label: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
arm group type: Active Comparator
description: Radiotherapy (RT) plus temozolomide (TMZ) and enzastaurin (ENZ) (Concurrent Phase) followed by enzastaurin alone (Single-Agent Phase), then temozolomide and enzastaurin (Adjuvant Phase)
arm group label: RT plus TMZ and placebo; placebo; TMZ and placebo
arm group type: Placebo Comparator
description: Radiotherapy (RT) plus temozolomide (TMZ) and placebo followed placebo then by temozolomide and placebo
intervention type: Drug
intervention name: Enzastaurin Hydrochloride
description: mg
arm group label: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
other name: Kinenza
intervention type: Other
intervention name: Placebo
description: mg
arm group label: RT plus TMZ and placebo; placebo; TMZ and placebo
intervention type: Drug
intervention name: Temozolomide
description: mg/m^2
arm group label: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
arm group label: RT plus TMZ and placebo; placebo; TMZ and placebo
other name: Temodar
intervention type: Radiation
intervention name: Radiotherapy
description: Gy
arm group label: RT plus TMZ and ENZ; ENZ alone; TMZ and ENZ
arm group label: RT plus TMZ and placebo; placebo; TMZ and placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: China
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Temozolomide