A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

September 30, 2010

Study Completion Date

June 30, 2012

Conditions
CancerCarcinomaColon CancerColorectal CancerGastrointestinal CancerMetastasesMetastatic CancerMetastatic Colorectal CancerOncologyRectal Cancer
Interventions
DRUG

AMG 386

AMG 386 (10 mg/kg QW) will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.

DRUG

AMG 386 Placebo

AMG 386 placebo QW will be administered until subject develops disease progression, clinical progression, unacceptable toxicity, or withdraws consent.

DRUG

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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT00752570 - A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma | Biotech Hunter | Biotech Hunter