Olaparib in Recurrent IDH-mutant Glioma
- Sponsor
- Hospices Civils de Lyon
- Study ID
- NCT03561870
- Phase
- PHASE2
- Status
- Completed
Conditions
- Mutant High Grade Glioma
- Recurrent IDH
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib 150 MG — DRUGOlaparaib: 600 mg/day: 300 mg BID (2 x 150 mg tablets taken orally) each 28 days cycle, until disease progression or unacceptable toxicity
Study Details
Recent data demonstrate that in IDH-mutant gliomas, 2 hydroxy-glutarate production induces a homologous recombination defect that renders tumor cells exquisitely sensitive to poly(adenosine 5'-diphosphate-ribose) polymerase (PARP) inhibitors, including olaparib (Lynparza; AstraZeneca). The aim of this open-label phase 2 study is to evaluate the efficacy of olaparib in in recurrent IDH-mutant high grade gliomas based on 6 months progression-free survival.
Key Dates
- Start date
- Mar 20, 2019
- Status verified
- Apr 2022
- Primary completion
- Nov 8, 2021
- Completion
- Nov 24, 2021
Study Design
- Enrollment
- 35 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Olaparib
Primary Outcome Measure
progression free survival [ Time Frame: 6 months ]