Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma (NCT05076513) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
United States42 participantsStarted 2021-10-29
Plain-language summary
This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Arm A participants undergoing resection for a suspected newly diagnosed glioblastoma. For Arm B, participants undergoing resection who have had a prior resection of histologically diagnosed WHO grade II-IV glioma with IDH1 or IDH2 mutation and ATRX loss.
✓. Arm A participants must have measurable disease preoperatively, defined as at least 1 contrast-enhancing lesion, with 2 perpendicular measurements of at least 1 cm.
✓. Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
✓. Participant has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
✓. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
✓. Age ≥18 at time of consent
✓. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology (Group (ECOG) scale (Oken et al. 1982)
✓
What they're measuring
1
Phase 0 Arm A: Total and unbound niraparib concentration in enhancing and nonenhancing tissue
Timeframe: Day 4 Intra-operative sample
2
Phase 0 Arm B: Presence of Chromosomal fusion
Timeframe: Day 4 Intra-operative sample
3
Phase 0 Expansion Arm A: Progression-free survival in participants with demonstrated PK effects
Timeframe: 6 months
4
Phase 0 Expansion Arm B: Progression-free survival in participants with demonstrated PD effects
✕. Current use of coumarin-derived anticoagulant for treatment, prophylaxis or otherwise, that cannot be discontinued prior to surgery. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
✕. Pregnancy or lactation.
✕. Known allergic reactions to components of the niraparib tablet, including FD\&C Yellow No. 5..
✕. Active infection or fever \>38.5°C requiring systemic antibiotic, antifungal or antiviral therapy within 4 weeks of Day 1.
✕. Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis as determined by the investigator.
✕. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
✕. Any of the following cardiovascular criteria:
✕. Participant has myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.