Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT03943173
- Phase
- EARLY_PHASE1
- Status
- Active Not Recruiting
Conditions
- BRCA-Mutated Ovarian Carcinoma
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- High Grade Fallopian Tube Serous Adenocarcinoma
- High Grade Ovarian Serous Adenocarcinoma
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Chemotherapy — DRUGGiven standard chemotherapy
- Olaparib — DRUGGiven PO
- Therapeutic Conventional Surgery — PROCEDUREUndergo surgery
Study Details
This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Key Dates
- Start date
- Jun 7, 2019
- Status verified
- Aug 2025
- Primary completion
- Jun 27, 2027
- Completion
- Jun 27, 2027
Study Design
- Enrollment
- 15 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (olaparib)Patients receive olaparib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After treatment, patients either undergo surgery then receive standard chemotherapy for up to 4 cycles or receive standard chemotherapy within 14 days for up to 4 cycles then undergo surgery in the absence of disease progression or unacceptable toxicity at the discretion of the treating physician.
Primary Outcome Measure
Feasibility of olaparib [ Time Frame: Up to 1 year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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