A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Demcizumab

The 6 subjects in the first cohort will receive demcizumab 5 mg/kg once every 3 weeks; the 6 subjects in the subsequent cohort will be treated with 10 mg/kg once every 3 weeks; and the 6 subjects in the final cohort will be treated with 15 mg/kg once every 3 weeks. A Data Safety Monitoring Board (DSMB) will review the data for the 6 subjects in each dose cohort after the last subject in that cohort has been on study for 56 days and then decide whether it is safe to escalate to the next highest dose cohort. Once the dose-escalation portion of the study has been completed, 14 additional subjects will be treated at the highest dose level that the DSMB deems as safe.

Trial Locations (7)

3168

Monash Medical Centre, Clayton

4029

Royal Brisbane & Women's Hospital, Herston

5037

Ashford Cancer Centre Research, Kurralta Park

6009

Sir Charles Gairdner Hospital, Nedlands

Unknown

Auckland Hospital, Grafton

Waikato Hospital, Hamilton

START Madrid, Madrid

Sponsors
All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

OncoMed Pharmaceuticals, Inc.

INDUSTRY