drugset / Trial / NCT01859741
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2012-01-07
- Primary completion
- 2017-04-18
- Completion
- 2017-05-08
Outcome
Outcome not reported
Stopped: “OMP-59R5 did not improve PFS.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tarextumab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |