A Study Assessing BGB-290 With Radiation and/or Temozolomide (TMZ) in Subjects With Newly Diagnosed or Recurrent Glioblastoma



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/17/2019
Start Date:June 30, 2017
End Date:October 31, 2021
Contact:Katie Wood
Email:clinicaltrials@beigene.com
Phone:1 (877) 828-5568

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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

This study is to evaluate the safety, efficacy and clinical activity of BGB-290 in
combination with radiation therapy (RT) and/or temozolomide (TMZ) in subjects with newly
diagnosed or recurrent/refractory glioblastoma.

An open‑label, multiple‑dose, dose-escalation study to determine the safety, pharmacokinetics
(PK) and pharmacodynamics (PD) of BGB-290 in combination with radiation therapy (RT) and/or
TMZ with 2 arms and a potential third arm.

In dose escalation/Phase 1b, BGB-290 will be combined with RT (Arm A) or RT and TMZ (Arm B)
in subjects with newly diagnosed unmethylated glioblastoma (GB), or BGB-290 will be combined
with TMZ in subjects with methylated or unmethylated recurrent/refractory GB (Arm C).

The dose expansion/Phase 2 phase will enroll up to 4 cohorts: subjects with newly diagnosed
unmethylated GB in Arm A and Arm B, and 2 potential cohorts of subjects with unmethylated and
methylated recurrent/refractory GB in Arm C. Subjects in dose expansion may continue
treatment in the absence of safety concerns and disease progression.

Inclusion Criteria: All subjects

1. Age ≥ 18 years old.

2. Confirmed diagnosis of glioblastoma (WHO Grade IV).

3. Ability to undergo serial MRIs.

4. ECOG status ≤ 1.

5. Adequate bone marrow function.

6. Adequate renal and hepatic 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
90 days after last dosing.

8. Ability to swallow whole capsules.

Subjects in Arms A and B (not Arm C) must also meet inclusion criteria 9 - 10:

9. No previous treatment for GB 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.

Subjects in Arm C must also meet inclusion criteria # 12 - 14:

12. No prior systemic chemotherapy other than TMZ for GB.

13. Progressive disease > 2 months after completion of first line therapy.

14. At least one measurable lesion by mRANO.

Subjects in Arm C Phase 2, Cohort C1 must also meet criteria # 15. This is not
applicable to subjects enrolled in Arm C, Ph 1b.

15. Documentation of unmethylated MGMT promoter status.

Subjects in Arm C Phase 2, Cohort C2 must also meet Criteria #16. This is not
applicable to subjects enrolled in Arm C Phase 1b.

16. Documentation of methylated MGMT promoter status.

Exclusion Criteria: All subjects

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. Uncontrolled seizure disorder.

6. Active infection requiring systemic treatment.

7. Known human immunodeficiency virus (HIV) or active viral hepatitis.

8. Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease,
ventricular arrhythmia or CVA ≤ 6 months prior to start of treatment.

9. Active clinically significant gastrointestinal disease.

10. Active bleeding disorder ≤ 6 months prior to start of treatment.

11. Need for therapeutic anti-coagulation with heparin, warfarin or other anticoagulants.

12. Use of any medications or food known to be strong or moderate cytochrome P450, family
3, subfamily A (CYP3A) inhibitors or strong inducers.

13. Pregnant or nursing females.

14. Significant intercurrent illness that may result in subject's death prior to death
from glioblastoma.

15. Known hypersensitivity to any component of TMZ or decarbazine (DTIC). [Subjects in
Arms B and C only.]
We found this trial at
17
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San Francisco, California 94143
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Deborah Forst, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Manmeet Ahluwalia, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
Principal Investigator: Michael Badruddoja, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Patrick Wen, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlottesville, Virginia 22908
Principal Investigator: David Schiff, MD
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Vinay Puduvalli, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1800 North Williams Street
Denver, Colorado 80218
Principal Investigator: Michael Pearlman, MD
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Detroit, Michigan 48202
Principal Investigator: Tobias Walbert, MD
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Liverpool, New South Wales 2170
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Los Angeles, California 90095
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Nashville, Tennessee 37203
Principal Investigator: Kent Shih, MD
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
Principal Investigator: James Battiste, MD
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Lyndon Kim, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Louis, Missouri 63110
Principal Investigator: Jian Campian, MD
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Salt Lake City, Utah 84112
Principal Investigator: Howard Colman, MD
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