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NCT03749187Active, not recruitingPhase 1

BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas

A Target Validation/Phase1 Study of BGB-290 in Combination With Temozolomide in Adolescent and Young Adult IDH1/2 Newly Diagnosed and Recurrent Mutant Gliomas

Source: ClinicalTrials.gov · Last updated 13 Mar 2026

Brief summary (registry, in English)

This phase I trial studies the side effects and best dose of BGB-290 and temozolomide in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma that is newly diagnosed or has come back. BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BGB-290 and temozolomide may work better in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
78 (estimated)
First submitted
19 Nov 2018
Start date
3 Apr 2019
Primary completion date
30 Jun 2026
Lead sponsor
University of California, San Francisco
NCT number
NCT03749187

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 78
  • From 3 Apr 2019 to the primary completion date, 30 Jun 2026
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who are receiving any other investigational agents at any time may not be enrolled.
  • Participants who have received a PARP inhibitor previously.
  • Participants with clinically significant active bleeding disorder, hemoptysis, or melena =\< 6 months prior to day 1.
  • Unresolved acute effects of any prior therapy of grade \>= 2, except for adverse events (AEs) not constituting a safety risk by investigator judgement.
  • Use =\< 10 days (or =\< 5 half-lives, whichever is shorter) prior to day 1 or anticipated need for food or drugs known to be strong or moderate Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers.
  • Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pamiparib (BGB-290) and TMZ. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Participants with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

Other illness

  • Participants with active infection requiring antibiotics at time of therapy start.
  • Participants with other diagnosis of malignancy.
  • Participants with known disseminated leptomeningeal disease.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ or pamiparib (BGB-290).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Lab values

  • Participants on therapeutic anti-coagulation with heparin, warfarin, or other anticoagulants:
    • Use of low-dose aspirin and/or non-steroidal anti-inflammatory agents are allowed.
    • Use of thrombolytic to establish patency of indwelling venous catheters is allowed.
    • Prophylactic anticoagulation for venous access devices is allowed as long as institutional normalized ratio (INR) is =\< 1.5 and partial thromboplastin time (aPTT) =\< 1.5 x institutional ULN.
    • Use of low-molecular weight heparin is allowed.
  • Female participants of childbearing potential must not be pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days of first dose.

Other

  • Participants with diffuse intrinsic pontine glioma (DIPG) are not eligible for this study.

Who the study is looking for

  • Arm A Only: Participants must have histologically confirmed World Health Organization (WHO) grade III-IV newly diagnosed IDH1/2-mutant glioma.
  • Arm B Only: WHO grades I-IV recurrent IDH1/2 mutant glioma. Participants in Arm B must have magnetic resonance imaging (MRI) confirming progressive disease; re-biopsy is encouraged, but not required at the time of recurrence for confirmation.
  • Participants with a primary spinal tumor, secondary glioma, or multifocal disease in the brain, but without evidence of diffuse leptomeningeal spread, are eligible. In cases where there are questions about multifocality versus diffuse leptomeningeal spread, the study chair or co-chair must be contacted to make a final decision on eligibility.
  • Participants must have IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins.
  • Participants must be willing to provide archival formalin-fixed embedded (FFPE) and frozen tissue specimens for biomarker studies if available.
  • Participants in Arm A must have been treated with maximal safe resection of primary tumor followed by adjuvant radiation therapy (RT). Treatment with TMZ during radiation is allowed but not required.
  • Participants in Arm B must have been treated with maximal safe resection of tumor.
    • Lower grade glioma (LGG) participants who progressed after initial surgery alone are eligible. Any number of prior therapies are allowed.
    • High grade glioma (HGG) participants enrolled on Arm B must have been treated with a minimum of maximal safe resection of primary tumor followed by adjuvant RT prior to recurrence. Any number of prior therapies are allowed.
  • Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  • Myelosuppressive chemotherapy: participants must have received their last dose of known myelosuppressive anticancer chemotherapy at least three weeks prior to study registration or at least six weeks if nitrosourea.
  • Biologic agent: participants must have recovered from any toxicity related to biologic agents and received their last dose \>= 7 days prior to study registration.
    • For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval should be discussed with the study chair.
    • For biologic agents that have a prolonged half-life, the appropriate interval since last treatment should be discussed with the study chair prior to registration.
  • Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration, and participants on bevacizumab must have received their last dose \>= 32 days prior to study registration.
  • Participants in Arm A should begin therapy with TMZ and BGB-290 after completion of radiation therapy and when all other eligibility criteria are met.
  • For participants in Arm B, patients must not have received radiation therapy within 4 weeks prior to the initiation of study treatment. Post-RT, the diagnosis of true progression versus pseudo-progression can be challenging when imaging modalities are exclusively used, and thus an additional resection is encouraged if clinically indicated.
  • Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3.
  • Platelet count \>= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
  • Hemoglobin \>= 9 g/dL.
  • Serum creatinine =\< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \>= 50 mL/min (calculated using the institutional standard method).
  • Total serum bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN).
  • Aspartate and alanine aminotransferase (AST and ALT) =\< 3 x ULN.
  • Serum albumin \>= 2 g/dL.
  • Participants with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled.
  • Participants who have neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.
  • Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
  • The effects of BGB-290 on the developing human fetus are unknown. For this reason and because alkylating agents (such as TMZ) are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 4 months after completion of BGB-290 or TMZ administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Participants must be able to swallow capsules.
  • Participants must have the ability to undergo serial MRI scans (computerized tomography \[CT\] cannot substitute for MRI).
  • A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
  • Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

Age in the registry: 13 years to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins University/Sidney Kimmel Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
Children's Hospital Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.