Spots Global Cancer Trial Database for 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

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety and tolerability of olaparib in sequential treatment with adavosertib (AZD1775). II. To establish the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of this sequential schedule in patients with advanced solid tumors in a post-poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi) population. III. To assess the safety and toxicity profile of the sequential treatment of olaparib and AZD1775 in a post-PARPi population. SECONDARY OBJECTIVES: I. To assess putative predictive biomarkers of response and resistance to the sequential treatment of olaparib and AZD1775 in a post-PARPi population. II. To evaluate a novel experimental trial design involving sequential dosing of olaparib and AZD1775 in a post-PARPi population. III. To observe and record anti-tumor activity. OUTLINE: This is a dose-escalation study of adavosertib. Patients receive olaparib orally (PO) twice daily (BID) on days 1-5 and 15-19 of each cycle and adavosertib PO once daily (QD) on days 8-12 and 22-26 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 2 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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