Active — Not RecruitingPhase 2

Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

United States89 participantsStarted 2019-01-30

Plain-language summary

This phase II trial studies how well olaparib works in treating patients with glioma, cholangiocarcinoma, or solid tumors with IDH1 or IDH2 mutations that has spread from where it first started (primary site) to other places in the body (metastatic) and that does not respond to treatment (refractory). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures; patients with Impaired Decision Making Capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) may be considered eligible for this study at the treating physician's discretion, provided that the physician is reasonably sure that the possible risks and benefits of the study are clear and that the patient will take the drug as prescribed * Subjects must be diagnosed with a glioma, cholangiocarcinoma or other solid malignant tumor that has progressed despite standard therapy, or for which no effective standard therapy exists, with biopsy-confirmed evidence of an IDH1 or IDH2 mutation associated with neomorphic activity of the encoded proteins; patients must have IDH1 or IDH2 mutation which must be detected in a clinical accredited laboratory using a Food and Drug Administration (FDA)-approved molecular test or a validated deoxyribonucleic acid (DNA)-based assay conducted in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; only specific mutations that lead to a neomorphic phenotype will be eligible for enrollment, and include IDH1: R132V, R132G, R132S, R132L, R132C and R132H; IDH2: R140W, R140L, R140Q, R172W, R172G, R172S, R172M, R172K * Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies (with a third b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is in Phase 2 and is testing olaparib specifically in tumors with IDH1 or IDH2 mutations — has my tumor been tested for these mutations, and if not, would it make sense to do that testing now?
2Since the trial is 'active but not recruiting,' new patients can't enroll — are there other trials or expanded access programs studying olaparib or similar PARP inhibitors for IDH-mutated tumors that I might still be able to join?
3The trial is measuring overall response rate as its main goal, which means we're still learning how well olaparib works for IDH-mutated glioma or cholangiocarcinoma — given that uncertainty, how does the potential benefit of this approach compare to standard treatments that already have more established safety and effectiveness data for my specific diagnosis?
4Olaparib is a PARP inhibitor originally developed for cancers with BRCA mutations — can you help me understand why it's being studied for IDH-mutated tumors, and what the known side effects are that I should be aware of if a similar drug becomes an option for me?
5Since my condition is a recurrent glioma or cholangiocarcinoma, would it be worth getting a second opinion at a center that specializes in IDH-mutated tumors, where they might have access to newer trials studying this same mutation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Response Rate

Timeframe: Up to completion of 8 weeks of treatment

Trial details

NCT IDNCT03212274

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-04-02

Results submitted2026-03-25

View on ClinicalTrials.gov More Advanced Malignant Solid Neoplasm trials