A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma
NCT ID: NCT03150862
Last Updated: 2025-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2017-07-24
2021-03-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Dose Escalation)
Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Pamiparib
Administered as specified in the treatment arm
Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Arm B (Dose Escalation)
Participants with newly diagnosed unmethylated GBM will receive Pamiparib, radiation therapy (RT) and temozolomide (TMZ).
Pamiparib
Administered as specified in the treatment arm
TMZ
Administered as specified in the treatment arm
Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Arm A (Dose Expansion)
Participants with newly diagnosed unmethylated GBM will receive Pamiparib and radiation therapy.
Pamiparib
Administered as specified in the treatment arm
Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Arm C (Dose Escalation)
Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Pamiparib
Administered as specified in the treatment arm
TMZ
Administered as specified in the treatment arm
Arm C (Dose Expansion-Cohorts C1 and C2)
Participants with recurrent/refractory methylated or unmethylated GBM will receive Pamiparib and TMZ.
Pamiparib
Administered as specified in the treatment arm
TMZ
Administered as specified in the treatment arm
Interventions
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Pamiparib
Administered as specified in the treatment arm
TMZ
Administered as specified in the treatment arm
Radiation
Up to 60 Gy (total) over 6 - 7 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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BeiGene USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Center For Neurosciences
Tucson, Arizona, United States
UCLA
Los Angeles, California, United States
University of California At San Francisco
San Francisco, California, United States
Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Midamerica Division, Inc
Kansas City, Missouri, United States
Washington University in St Louis
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Sarah Cannon Research Institute (Scri) Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital Jefferson Health
Philadelphia, Pennsylvania, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Institut Gustave Roussy
Villejuif, , France
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
University of Zurich Medical School
Zurich, , Switzerland
Countries
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References
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Xiong Y, Guo Y, Liu Y, Wang H, Gong W, Liu Y, Wang X, Gao Y, Yu F, Su D, Wang F, Zhu Y, Zhao Y, Wu Y, Qin Z, Sun X, Ren B, Jiang B, Jin W, Shen Z, Tang Z, Song X, Wang L, Liu X, Zhou C, Jiang B. Pamiparib is a potent and selective PARP inhibitor with unique potential for the treatment of brain tumor. Neoplasia. 2020 Sep;22(9):431-440. doi: 10.1016/j.neo.2020.06.009. Epub 2020 Jul 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001554-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BGB-290-104
Identifier Type: -
Identifier Source: org_study_id
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