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
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Malignant Solid Neoplasm
- Refractory Malignant Solid Neoplasm
- Unresectable Malignant Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04197713
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy A Yap University of Texas MD Anderson Cancer Center LAO