Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Phase 1

Terminated

• Conditions: Neoplasms

• Registration Number: NCT00257881
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-22
• Study First Submitted QC: 2005-11-22
• Study First Posted: 2005-11-23
• Study Completion: 2006-12
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-06
• Last Update Posted: 2007-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Malignant solid tumor progressed, or no standard treatment available
• Tumor expression of Lewis Y antigen

Exclusion Criteria

• Cancer therapy within 28 days before enrollment
• Pregnant or breastfeeding women
• Unstable or serious concurrent medical conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity, Adverse Event

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters, Tumor assessment