A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer
- Conditions
- platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer
- Registration Number
- JPRN-UMIN000026475
- Lead Sponsor
- RG Oncology Group
- Brief Summary
npublished
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 578
Not provided
Patients who have had chemotherapy or radiotherapy within 4 weeks of starting treatment prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, or had hormonal therapy within 2 weeks prior to entering the study. Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks, nor receiving any medication that may markedly affect renal function, nor have received prior treatment affecting the VEGF pathway, nor have previously received a PARP inhibitor. Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib. Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. History of gastrointestinal perforation. History of intra-abdominal abscess within the past 3 months. Current signs and/or symptoms of bowel obstruction or signs. Dependency on IV hydration or TPN. Any concomitant or prior invasive malignancies with the following curatively treated exceptions. History of myocardial infarction within six months,Unstable angina,Resting ECG with clinically significant abnormal findings,NYHA classification of III or IV. History of stroke or transient ischemic attack within six months. Any prior history of hypertensive crisis or hypertensive encephalopathy. Clinically significant peripheral vascular disease or vascular disease. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib. Uncontrolled intercurrent illness. Pregnant women Known HIV-positive individuals. No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method