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NCT02092363 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
A Phase 1 study of Ovarian Cancer, sponsored by OncoMed Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 4
- Study locations
NCT02092363 is a Phase 1 study of Ovarian Cancer that has completed, run by OncoMed Pharmaceuticals. The registered enrollment target is 37 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT02092363, a Phase 1 study of Ovarian Cancer, has completed, sponsored by OncoMed Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL • min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and carboplatin will be given. Additional cycles may be given as per institutional standard of care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28 are 5 and 10 mg/kg.
Conditions Studied
Interventions
- DRUG OMP-54F28, Paclitaxel and Carboplatin
Study Locations (4)
Pennsylvania
- The University of Pennsylvania Health System - Philadelphia
- Fox-Chase Cancer Center - Philadelphia
New York
- Memorial Sloan Kettering Cancer Center - New York
Oklahoma
- OU Medical Center Laboratory - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-01 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02092363
The ClinicalTrials.gov registry entry for NCT02092363 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (95% lower). The listed sponsor is OncoMed Pharmaceuticals, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which OMP-54F28, Paclitaxel and Carboplatin is the first listed.
NCT02092363 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, New York, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT02092363 about?
NCT02092363 is a clinical study titled "Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer". This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL • min) will be administe...
What is the current status of trial NCT02092363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2014-01. Estimated completion is 2017-12.
What conditions does trial NCT02092363 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT02092363?
The interventions under investigation include: OMP-54F28, Paclitaxel and Carboplatin (DRUG).
Who is sponsoring clinical trial NCT02092363?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02092363 being conducted?
This trial has 4 study locations across New York, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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