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NCT02482441 · ClinicalTrials.gov registry record · Phase 1
A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10
A Phase 1 study of Refractory Solid Tumors and Advanced Relapsed Tumors, sponsored by OncoMed Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 7
- Study locations
NCT02482441: Completed Phase 1 study of Refractory Solid Tumors and Advanced Relapsed Tumors, sponsored by OncoMed Pharmaceuticals.
NCT02482441 is a Phase 1 study of Refractory Solid Tumors and Advanced Relapsed Tumors that has completed, run by OncoMed Pharmaceuticals. The registered enrollment target is 50 participants, below the 1,460-participant average among 7 other Refractory Solid Tumors trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02482441, a Phase 1 study of Refractory Solid Tumors and Advanced Relapsed Tumors, has completed, sponsored by OncoMed Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
Primary Outcome
Subject will be assessed for DLTs during the evaluation window (28 days). Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined.
Conditions Studied
Interventions
- DRUG FOLFIRI
- DRUG OMP-131R10
Study Locations (7)
California
- UCSF - San Francisco
Colorado
- University of Colorado Hospital Anschulz Cancer Pavilion - Aurora
Connecticut
- Yale - New Haven
Massachusetts
- Massachusetts General Hospital, Dana Farber Cancer Institute - Boston
North Carolina
- Duke University - Durham
Tennessee
- The Sarah Cannon Research Institute - Nashville
Texas
- M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-07-16 |
| Est. Completion | 2018-03-28 |
| Phase | Phase 1 |
What the finished NCT02482441 record still lists
NCT02482441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,460-participant average among 7 other Refractory Solid Tumors trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Refractory Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which FOLFIRI is the first listed.
NCT02482441 lists 7 locations in 7 states (California, Colorado, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02482441 about?
NCT02482441 is a clinical study titled "A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10". This is an open-label Phase 1a/b dose-escalation study to assess the safety, tolerability, and PK of OMP-131R10 as a single agent for advanced solid tumors and in subjects with metastatic colorectal cancer.
What is the current status of trial NCT02482441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2015-07-16. Estimated completion is 2018-03-28.
What conditions does trial NCT02482441 study?
This clinical trial studies the following conditions: Refractory Solid Tumors, Advanced Relapsed Tumors.
What interventions are being tested in trial NCT02482441?
The interventions under investigation include: FOLFIRI (DRUG), OMP-131R10 (DRUG).
Who is sponsoring clinical trial NCT02482441?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02482441 being conducted?
This trial has 7 study locations across California, Colorado, Connecticut, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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