Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD… (NCT04197713) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study
United States13 participantsStarted 2020-06-30
Plain-language summary
This phase I trial studies the side effects and best dose of adavosertib when given together with olaparib in treating patients with solid tumors that have spread to other places in the body (advanced) with selected mutations. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Giving olaparib and adavosertib one after the other may shrink or stabilize advanced solid tumors as successfully as using them together, with fewer side effects.
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 have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
* Patients in dose expansion Cohort A (intrinsic resistance), must have:
* Prior treatment with PARP inhibitors
* Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) at 1st re-staging, and
* Germline or somatic mutations in BRCA1 or BRCA2
* Patients in dose expansion Cohort B (acquired resistance) must have:
* Prior treatment with PARP inhibitors,
* Complete/partial response followed by disease progression per RECIST, and
* Germline or somatic mutations in any of the following deoxyribonucleic acid (DNA) damage response (DDR) genes: BRCA1, BRCA2, BRIP1, FANCA, PALB2, or the non-DDR gene marker cyclin E amplification. Local testing in Clinical Laboratory Improvement Act (CLIA)-certified laboratory will be accepted. All alterations will be reviewed by MD Anderson's Precision Oncology Decision Support (PODS) team. No variants of uncertain significance (VUS) will be allowed as the qualifying genetic mutation. Recruitment of patients with relevant molecular aberrations in the dose escalation phase is encouraged but not mandated.
* Subjects must have RECIST measurable disease and a tumor that is safely accessible for biopsy and must be willing to undergo biopsy
* Subjects must have received at least one line of systemic therapy in the advanced/metastat…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Dose Limiting Toxicity
Timeframe: Within the first cycle (28 days) of treatment
2
Incidence and Causality of Treatment-Related Adverse Events
Timeframe: Approximately 2 years and 7 months. For each enrolled patient, adverse event data was captured from the period in which a patient signed the informed consent and up to 90 days after the administration of the last dose of study drug.