Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance
- Conditions
- Advanced FIGO Stage IIIB-IV High Grade Serous or Endometrioid Ovarian,Fallopian Tube, or Peritoneal Cancer
- Registration Number
- JPRN-UMIN000019560
- Lead Sponsor
- GOTIC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 24
Not provided
1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum 2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma. 3.Patient with synchronous primary endometrial cancer unless both of the following criteria are met: stage < II, Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade III endometrioid adenocarcinoma OR over 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1 or 2 endometrioid adenocarcinoma. 4.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS). Patient with a history of localized malignancy diagnosed over 5 years ago may be eligible provided she completed her adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease. Patient with history of primary triple negative breast cancer may be eligible provided she completed her definitive anticancer treatment more than 3 years ago and she remains breast cancer disease free prior to start of study treatment. 5.Patient with myelodysplastic syndrome/acute myeloid leukemia history. 6.Patient having experienced for at least one cycle, a delay > 2 weeks due to prolonged hematological recovery during the first line chemotherapy. 7.Patient receiving radiotherapy within 6 weeks prior to study treatment. 8.Major surgery within 4 weeks of starting study treatment and patient must have recovered from any effects of any major surgery. 9.Previous allergenic bone marrow transplant. 10.Any previous treatment with PARP inhibitor, including olaparib. et cetera
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method