FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer
Public ClinicalTrials.gov record NCT02641639. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
FOCUS: A Multicenter, Multinational, Double-Blind, 2-Arm, Randomized, Phase 2/3, Study of Physician's Choice Chemotherapy ([PCC] Weekly Paclitaxel or Pegylated Liposomal Doxorubicin [PLD]) Plus Bevacizumab and CA4P Versus PCC Plus Bevacizumab and Placebo for Subjects With Platinum-Resistant, Recurrent Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02641639
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2016 (Actual)
- Primary completion
- Oct 2017 (Actual)
- Completion
- Oct 2017 (Actual)
- Last update posted
- Mar 24, 2025
2016 – 2017
United States locations
- U.S. sites
- 36
- U.S. states
- 17
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35249 | — |
| Mitchell Cancer Institute - USA Health System | Mobile | Alabama | 36604 | — |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | — |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | — |
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| Oncology Institute of Hope and Innovation | Lynwood | California | 90262 | — |
| University of California Irvine | Orange | California | 92868 | — |
| California Pacific Medical Center, Research Institute | San Francisco | California | 94115 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| Rocky Mountain Cancer Centers, LLP | Lakewood | Colorado | 80228 | — |
| Hartford Health Care Cancer Institute; Affiliate Memorial Sloan Kettering | Hartford | Connecticut | 06102 | — |
| Stamford Hospital - Bennett Cancer Center | Stamford | Connecticut | 06904 | — |
| Sylvester Comprehensive Cancer Center University of Miami | Miami | Florida | 33136 | — |
| Baptist Health Medical Group Oncology, LLC | Miami | Florida | 33176 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Maine Medical Center | Scarborough | Maine | 04074 | — |
| Mercy Medical Center; The Institute for Cancer Care | Baltimore | Maryland | 21202 | — |
| HCA Midwest Division - Sarah Cannon Cancer Institute | Kansas City | Missouri | 64132 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Oklahoma Heath Sciences Center - Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Tulsa Cancer Institute | Tulsa | Oklahoma | 74146 | — |
| OHSU Center for Women's Health & Knight Cancer Institute | Portland | Oregon | 97239 | — |
| Willamette Valley Cancer Institute | Springfield | Oregon | 97477 | — |
| Lehigh Valley Hospital, John and Dorothy Morgan Cancer Center; Affiliate Memorial Sloan Kettering | Allentown | Pennsylvania | 18103 | — |
| The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Gibbs Cancer Center & Research Institute Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| Texas Oncology, P.A. | Austin | Texas | 78731 | — |
| Texas Oncology | Bedford | Texas | 76022 | — |
| Dallas County Hospital District d/b/a Parkland Health and Hospital System | Dallas | Texas | 75235 | — |
| Simmons Comprehensive Cancer Center; UT Southwestern Medical Center | Dallas | Texas | 75235 | — |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | — |
| Texas Oncology San Antonio | San Antonio | Texas | 78229 | — |
| Texas Oncology, P.A. | The Woodlands | Texas | 77380 | — |
| Texas Oncology, P.A. | Tyler | Texas | 75702 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02641639, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02641639 live on ClinicalTrials.gov.