Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01647828 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
A Phase 1 study, sponsored by OncoMed Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
NCT01647828: Completed Phase 1 study, sponsored by OncoMed Pharmaceuticals.
NCT01647828 is a Phase 1 study that has completed, run by OncoMed Pharmaceuticals. The registered enrollment target is 217 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01647828, a Phase 1 study, has completed, sponsored by OncoMed Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
Study Summary
The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously untreated stage IV pancreatic cancer.
Primary Outcome
Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).
Interventions
- DRUG Placebo
- DRUG Nab-Paclitaxel
- DRUG Gemcitabine
- DRUG OMP-59R5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT01647828 record still lists
NCT01647828 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01647828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01647828 about?
NCT01647828 is a clinical study titled "A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer". The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2, multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of OMP-59R5 in combination with ...
What is the current status of trial NCT01647828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2012-10. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01647828?
The interventions under investigation include: Placebo (DRUG), Nab-Paclitaxel (DRUG), Gemcitabine (DRUG), OMP-59R5 (DRUG).
Who is sponsoring clinical trial NCT01647828?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01647828's enrollment target sits among peer trials
217 240th of 2000 higher than 1,758 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079282 · 217 participants · Phase 1
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
- NCT05470439 · 217 participants · NA
My Interprofessional Care Team for Adherence and Research Engagement Disparities
- NCT05981703 · 217 participants · Phase 1
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- NCT06342258 · 217 participants · Phase 1
COES: Curing Order Effects on Sealants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia