Olaparib in Recurrent IDH-mutant Glioma
NCT03561870 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-09-12
Summary
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.
Conditions
- Recurrent IDH
- Mutant High Grade Glioma
Interventions
- DRUG
-
Olaparib 150 MG
Olaparaib: 600 mg/day: 300 mg BID (2 x 150 mg tablets taken orally) each 28 days cycle, until disease progression or unacceptable toxicity
Sponsors & Collaborators
-
Hospices Civils de Lyon
lead OTHER
Principal Investigators
-
DUCRAY François, PUPH · GROUPEMENt Hospitaler EST
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-20
- Primary Completion
- 2021-11-08
- Completion
- 2021-11-24
Countries
- France
Study Locations
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