A Study of FOLFIRI Plus OMP-21M18 as 1st or 2nd-line Treatment in Subjects With Metastatic Colorectal Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Colorectal Cancer
Interventions
DRUG

OMP-21M18

The first 6 participants will receive OMP21M18 2.5 mg/kg once every other week, the next 6 participants will receive 5 mg/kg once every other week, and the final 6 participants will receive 10 mg/kg once every other week. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe.

Trial Locations (5)

2050

Sydney Cancer Centre, Camperdown

3240

Waikato Hospital, Hamilton

4029

Royal Brisbane & Women's Hospital, Herston

5037

Ashford Cancer Centre Research, Kurralta Park

6009

Sir Charles Gairdner Hospital, Nedlands

Sponsors
All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

OncoMed Pharmaceuticals, Inc.

INDUSTRY

NCT01189942 - A Study of FOLFIRI Plus OMP-21M18 as 1st or 2nd-line Treatment in Subjects With Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter