Active — Not RecruitingPhase 2

Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors

United States24 participantsStarted 2020-01-30

Plain-language summary

This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Laboratory studies have shown that olaparib and AZD6738 can shrink IDH mutant tumors or stop them from growing. Olaparib and ceralasertib 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 solid malignant tumor (other than cholangiocarcinoma or primary central nervous system \[CNS\] tumor) that has progressed despite standard therapy, or for which no effective standard therapy exists. Patients with cholangiocarcinoma are no longer allowed as this cohort has closed to accrual. Patients with primary CNS tumors, e.g. glioma, are not allowed * Patients must have biopsy-confirmed evidence of an IDH1 or IDH2 mutation, confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, associated with neomorphic activity of the encoded proteins * Patients must have tumors determined to be easily accessible for biopsy and must be willing to have serial biopsies. Tumor biopsies will be performed on the most accessible biopsiable site of disease. All possible precautions to avoid complications will be taken, including discussions in multidisciplinary meetings, if needed. If a patient opts out of a pre-tr…

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 testing two drugs together — olaparib and AZD6738 — specifically in tumors with IDH1 or IDH2 mutations. Has my tumor been tested for those mutations, and if so, would my specific mutation type make this combination worth discussing with you?
2Since this trial is Phase 2 and is no longer actively enrolling new patients, does that mean there's any chance of getting access to these drugs through a compassionate use or expanded access program, or is that door essentially closed?
3The trial is measuring whether the tumor actually shrinks or responds — called objective response rate — but what does that mean for real-world outcomes like how long I might live or how my quality of life could be affected, and how does that compare to standard treatment options for my type of cancer?
4Given that my diagnosis involves a refractory cancer — meaning it's already stopped responding to prior treatment — how does that history affect whether this kind of combination approach targeting IDH mutations might or might not be a good fit for where I am right now?
5Are there other currently enrolling trials or approved treatments targeting IDH1 or IDH2 mutations that we should be comparing against this study, since this one is no longer taking new patients?

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

Objective Response Rate (ORR)

Timeframe: Up to 30 days post treatment after removal from study

Trial details

NCT IDNCT03878095

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-03-12

Results submitted2026-03-02

View on ClinicalTrials.gov More Malignant Solid Neoplasm trials