Phase I Study of MEDI522 in Patients With Irinotecan-Refractory Advanced Colorectal Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

January 31, 2005

Study Completion Date

May 31, 2005

Conditions
Cancer
Interventions
DRUG

MEDI-522

Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 1 mg/kg for 51 weeks.

DRUG

MEDI-522

Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.

DRUG

MEDI-522

Administered as a 30-minute IV infusion; 6 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.

DRUG

MEDI-522

Administered as a 30-minute IV infusion; on Study Day 0 followed by weekly maintenance doses of 3mg/kg for 51 weeks.

DRUG

MEDI-522

The next cohort of patients will be treated after at least 3 of 4 patients treated in the previous cohort receive at least 3 weeks of treatment and experience no dose-limiting toxicity (DLT).

Trial Locations (1)

10021

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY