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

NCT00284817 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2008-05-29

No results posted yet for this study

Summary

\- Assess the safety and tolerance of a weekly MEDI522 regimen in patients with irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy.

Conditions

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).

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Krista Arbaugh, Dir., Clinical Ops · MedImmune LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2005-01-31
Completion
2005-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00284817 on ClinicalTrials.gov