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NCT03150862 | COMPLETED | Brain and Central Nervous System Tumors

A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
Sponsor:

BeiGene USA, Inc.

Brief Summary:

The primary objective of this study is to evaluate the safety, efficacy and clinical activity of Pamiparib in combination with radiation therapy (RT) and/or temozolomide (TMZ) in participants with newly diagnosed or recurrent/refractory glioblastoma.

Condition or disease

Brain and Central Nervous System Tumors

Intervention/treatment

Pamiparib

TMZ

Radiation

Phase

PHASE1

PHASE2

Detailed Description:

An open-label, multiple-dose, dose-escalation study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of Pamiparib in combination with radiation therapy (RT) and/or TMZ. In dose escalation/Phase 1b, Pamiparib will be combined with RT (Arm A) or RT and TMZ (Arm B) in participants with newly diagnosed unmethylated glioblastoma (GBM) and in Arm C of the study Pamiparib will be combined with TMZ in participants with methylated or unmethylated recurrent/refractory GBM. The dose expansion/Phase 2 phase will enroll up to 4 cohorts: participants with newly diagnosed unmethylated GBM in Arms A and B, and 2 cohorts of participants with recurrent/refractory GBM grouped by O-6-methylguanine-DNA methyltransferase (MGMT) status - unmethylated or methylated - in Arm C. Participants in Arms A and B are treated until completion of RT and participants in Arm C may continue treatment in the absence of safety concerns and disease progression.

Study Type : INTERVENTIONAL
Estimated Enrollment : 116 participants
Masking : NONE
Masking Description : No Masking
Primary Purpose : TREATMENT
Official Title : A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma
Actual Study Start Date : 2017-07-24
Estimated Primary Completion Date : 2021-03-17
Estimated Study Completion Date : 2021-03-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria: All participants
  • 1. Age ≥ 18 years old.
  • 2. Confirmed diagnosis of glioblastoma (WHO Grade IV).
  • 3. Agreement to provide archival tumor tissue for exploratory biomarker analysis
  • 4. Ability to undergo serial MRIs.
  • 5. Eastern Cooperative Oncology Group (ECOG) status ≤ 1.
  • 6. Adequate hematologic and end-organ function
  • 7. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last dosing.
  • 8. Ability to swallow whole capsules.
  • Participants in Arms A and B (not Arm C) must meet inclusion criteria # 9 - 11:
  • 9. No previous treatment for GBM except surgery.
  • 10. Able to start radiation therapy ≤ 49 days after surgery but ≥ 14 days after a biopsy or ≥28 days after an open biopsy or craniotomy with adequate wound healing.
  • 11. Documented unmethylated MGMT promoter status.
  • Participants in Arm C Escalation (Phase 1b) must meet inclusion criteria # 12 - 15:
  • 12. Documentation of MGMT promoter status
  • 13. No prior systemic chemotherapy other than TMZ for GBM.
  • 14. Histologically confirmed secondary glioblastoma
  • 15. Disease that is evaluable or measurable as defined by Response Assessment in Neuro-Oncology (RANO) criteria
  • Participants in Arm C Expansion (Phase 2), must meet criteria # 16 - 18:
  • 16. Histologically confirmed de novo (primary) glioblastoma with unequivocal first progressive disease (PD) after RT with concurrent/adjuvant TMZ chemotherapy
  • 17. Disease that is measurable as defined by RANO criteria
  • 18. Documentation of MGMT promoter status
  • Key Exclusion Criteria: All participants
  • 1. Prior chemotherapy, biologic therapy, immunotherapy or investigational agents ≤21 days prior to start of study treatment.
  • 2. Toxicity of ≥ Grade 2 from prior therapy.
  • 3. Major surgery or significant other injury ≤ 4 weeks prior to start of study treatment.
  • 4. History of other active malignancies within 2 years with exception of (i) adequately treated in situ cancer of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed \> 2 years ago with no evidence of disease and no treatment ≤ 2 years prior to study treatment.
  • 5. Active infection requiring systemic treatment.
  • 6. Known human immunodeficiency virus (HIV) or active viral hepatitis.
  • 7. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or Cerebrovascular Accident (CVA) ≤ 6 months prior to start of treatment.
  • 8. Active clinically significant gastrointestinal disease.
  • 9. Active bleeding disorder ≤ 6 months prior to start of treatment.
  • 10. Need for therapeutic anti-coagulation with heparin, warfarin or other anticoagulants.
  • 11. Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
  • 12. Pregnant or nursing females.
  • 13. Significant intercurrent illness that may result in participant's death prior to death from glioblastoma.
  • Arms B and C Only:
  • 14. Known hypersensitivity to any component of TMZ or decarbazine (DTIC).
  • 15. Have hereditary problems of galactose intolerance
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
    • A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma

    Location Details

    NCT03150862

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, Arizona

    Center for Neurosciences

    Tucson, arizona, United States, 85718

    Not yet recruiting

    United States, California

    UCLA Neuro-Oncology

    Los Angeles, California, United States, 90095

    Not yet recruiting

    United States, California

    University of California at San Francisco

    San Francisco, California, United States, 94143

    Not yet recruiting

    United States, Colorado

    Sarah Cannon Research Institute at Health One

    Denver, Colorado, United States, 80218

    Not yet recruiting

    United States, Massachusetts

    Massachusetts General Hospital Pappas Center for Neuro-Oncology

    Boston, Massachusetts, United States, 02214

    Not yet recruiting

    United States, Massachusetts

    Dana Farber Cancer Institute

    Boston, Massachusetts, United States, 02215

    Not yet recruiting

    United States, road cancer

    Henry Ford Health Systems

    Detroit, road cancer, United States, 48202

    Not yet recruiting

    United States, Missouri

    Health Midwest Ventures Group, LLC

    Kansas City, Missouri, United States, 64132

    Not yet recruiting

    United States, Missouri

    Washington University

    St. Louis, Missouri, United States, 63110

    Not yet recruiting

    United States, New York

    Memorial Sloan Kettering Cancer Center

    New York, New York, United States, 10065

    Not yet recruiting

    United States, Ohio

    Cleveland Clinic

    Cleveland, Ohio, United States, 44195

    Not yet recruiting

    United States, Ohio

    The Ohio State University

    Columbus, Ohio, United States, 43210

    Not yet recruiting

    United States, Oklahoma

    University of Oklahoma Health Sciences Center (Stephenson Cancer Center)

    Oklahoma City, Oklahoma, United States, 73104

    Not yet recruiting

    United States, Pennsylvania

    Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, United States, 17033

    Not yet recruiting

    United States, Pennsylvania

    Thomas Jefferson University

    Philadelphia, Pennsylvania, United States, 19107

    Not yet recruiting

    United States, Tennessee

    SCRI / Tennessee Oncology

    Nashville, Tennessee, United States, 37203

    Not yet recruiting

    United States, Utah

    Huntsman Cancer Center

    Salt Lake City, Utah, United States, 84112

    Not yet recruiting

    United States, Virginia

    University of Virginia Health Systems

    Charlottesville, Virginia, United States, 22903

    Not yet recruiting

    Netherlands,

    Erasmus University Medical Center

    Rotterdam, Netherlands, 3015 GD

    Not yet recruiting

    Switzerland,

    Zurich University Hospital - Department of Neurology

    Zurich, Switzerland, CH-8091