FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Platinum Resistant Ovarian Cancer
In brief
This is a multicenter, multinational, randomized, double-blind, 2-arm, parallel-group, Phase 2/3 study to evaluate the efficacy and safety of PCC plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in subjects with platinum-resistant ovarian cancers (prOC). Subjects with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal or fallopian tube cancer will be randomized 1:1 to receive PCC plus bevacizumab and CA4P or PCC plus bevacizumab and placebo. Subjects will be stratified by selected chemotherapy (PLD vs. paclitaxel), platinum free interval (\< 3 vs. 3 to 6 months from last platinum therapy to subsequent progression), and line of therapy (2nd vs. 3rd). This is a 2-part study, consisting of a Phase 2, exploratory study (Part 1) followed by a Phase 3, pivotal study (Part 2). Both parts of the study will have similar overall design. Approximately 80 subjects will be randomized into Part 1 and approximately 356 subjects will be randomized into Part 2.
Key facts
- Study ID
- NCT02641639
- Run by
- Mateon Therapeutics
- People needed
- 70
- Starts
- 2016-06-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2025-03-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
- Mitchell Cancer Institute - USA Health System — Mobile, Alabama, United States
- Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- University of Arizona Cancer Center — Tucson, Arizona, United States
- Oncology Institute of Hope and Innovation — Lynwood, California, United States
- University of California Irvine — Orange, California, United States
- California Pacific Medical Center, Research Institute — San Francisco, California, United States
- Sansum Clinic — Santa Barbara, California, United States
- Rocky Mountain Cancer Centers, LLP — Lakewood, Colorado, United States
- Hartford Health Care Cancer Institute; Affiliate Memorial Sloan Kettering — Hartford, Connecticut, United States
- Stamford Hospital - Bennett Cancer Center — Stamford, Connecticut, United States
- Sylvester Comprehensive Cancer Center University of Miami — Miami, Florida, United States
- Baptist Health Medical Group Oncology, LLC — Miami, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Augusta University — Augusta, Georgia, United States
- Maine Medical Center — Scarborough, Maine, United States
- Mercy Medical Center; The Institute for Cancer Care — Baltimore, Maryland, United States
- HCA Midwest Division - Sarah Cannon Cancer Institute — Kansas City, Missouri, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Gabrail Cancer Center — Canton, Ohio, United States
- Oklahoma Heath Sciences Center - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Tulsa Cancer Institute — Tulsa, Oklahoma, United States
- OHSU Center for Women's Health & Knight Cancer Institute — Portland, Oregon, United States
- Willamette Valley Cancer Institute — Springfield, Oregon, United States
Full record on ClinicalTrials.gov
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