144
Participants
Start Date
November 30, 2008
Primary Completion Date
September 30, 2010
Study Completion Date
June 30, 2012
AMG 386
AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
AMG 386 Placebo
AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.
FOLFIRI
"Administration of FOLFIRI chemotherapy will commence on day 1 of each dosing week following the administration of AMG 386.~FOLFIRI Q2W regimen: irinotecan 180 mg/m2 IV over 90 (+-15) minutes on Day 1, leucovorin 400 mg/m2 IV over 2 hrs on Day 1, 5 FU 400mg/m2 IV bolus, followed by 2400 mg/m2 continuous IV infusion over 46 hrs +- 2 hours.~FOLFIRI will be administered until disease progression, FOLFIRI intolerability, death, or study withdrawal by the subject, investigator, or sponsor, whichever occurs earliest."
Lead Sponsor
Amgen
INDUSTRY