NCT00284817

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

Phase I Study of MEDI522, a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer or Other Solid Tumors Refractory to Standard Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Assess the safety and tolerance of a weekly MEDI 522 regimen in patients with irinotecan-refractory advanced CRC. * Determine a Phase II recommended dose based on acceptable dose-limiting toxicity. Other considerations such as pharmacokinetic parameters may also be factored into the determination of a Phase II dose. The secondary objectives of the study are to: * Assess any antitumor activity of MEDI-522 in this patient population.

Conditions

• Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2001-07-01
• Primary completion: 2005-01-01
• Completion: 2005-05-01
• First posted: 2006-02-01
• Last updated: 2008-05-29

Locations

1 site across 1 country: United States