NCT01859741

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy

A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).

Conditions

• Stage IV Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	OMP-59R5	OMP-59R5 administered intravenously
DRUG	Etoposide	administered intravenously
DRUG	Placebo	administered IV
DRUG	Cisplatin or Carboplatin	administered intravenously

Timeline

• Start date: 2012-01-07
• Primary completion: 2017-04-18
• Completion: 2017-05-08
• First posted: 2013-05-22
• Last updated: 2020-09-09
• Results posted: 2019-05-01

Locations

35 sites across 1 country: United States