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NCT01859741 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy
A Phase 1 study, sponsored by OncoMed Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 172
- Enrollment target
NCT01859741: Clinical Trial Phase 1 study, sponsored by OncoMed Pharmaceuticals.
NCT01859741 is a Phase 1 study that was terminated before completion, run by OncoMed Pharmaceuticals. The registered enrollment target is 172 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (187% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859741, a Phase 1 study, was terminated before completion, sponsored by OncoMed Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 172 participants
- Enrollment target
Study Summary
The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.
Primary Outcome
To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Da
Interventions
- DRUG Placebo
- DRUG Etoposide
- DRUG Cisplatin or Carboplatin
- DRUG OMP-59R5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2012-01-07 |
| Est. Completion | 2017-05-08 |
| Phase | Phase 1 |
Why NCT01859741 stopped before completion
NCT01859741 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (187% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01859741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01859741 about?
NCT01859741 is a clinical study titled "A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy". The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination...
What is the current status of trial NCT01859741?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 172 participants. The study started on 2012-01-07. Estimated completion is 2017-05-08.
What interventions are being tested in trial NCT01859741?
The interventions under investigation include: Placebo (DRUG), Etoposide (DRUG), Cisplatin or Carboplatin (DRUG), OMP-59R5 (DRUG).
Who is sponsoring clinical trial NCT01859741?
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 NCT01859741's enrollment target sits among peer trials
172 324th of 2000 higher than 1,677 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
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