Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 70
Summary
- Conditions
- Recurrent Fallopian Tube Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) of adavosertib (AZD1775) alone or in combination with olaparib in women with recurrent ovarian cancer in whom progression has been documented fo...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) of adavosertib (AZD1775) alone or in combination with olaparib in women with recurrent ovarian cancer in whom progression has been documented following poly ADP-ribose polymerase (PARP) inhibitor therapy. SECONDARY OBJECTIVES: I. To evaluate the overall safety and tolerability of AZD1775 alone or in combination with olaparib in this population. II. To evaluate the disease control rate (DCR) = overall response rate (ORR) plus stable disease rate for 16 weeks. III. To evaluate the progression free survival (PFS) and overall survival (OS) of this population following AZD1775 alone or in combination with olaparib. IV. To evaluate the duration of response by RECIST version (v)1.1. EXPLORATORY OBJECTIVES: I. To evaluate the efficacy of each arm by BRCA-mutation status (BRCA-mt) and homologous recombination deoxyribonucleic acid (DNA) repair deficiencies (HRD). II. To describe endogenous and dynamic markers of DNA damage response in tumor tissue and circulating surrogates, such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA), exosomes (cellular/nuclear), cell cycle kinetics (CDKs), and immunophenotype. III. To examine genomic alterations associated with response and mechanisms of resistance to olaparib and/or AZD1775. OUTLINE: Patients are randomized to 1 of 2 arms. If enrollment pauses for 1 arm, patients will be assigned to the enrolling arm. ARM I: Patients receive adavosertib orally (PO) once daily (QD) on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive olaparib PO twice daily (BID) on days 1-21 and adavosertib PO QD on days 1-3 and 8-10. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and periodically afterwards.
Tracking Information
- NCT #
- NCT03579316
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Shannon Westin M.D. Anderson Cancer Center