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

Neoplasms Clinical Trial

Official title:

Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00257881
• Other study ID #: 3152K1-101
• Status: Terminated
• Phase: Phase 1
• First received: November 22, 2005
• Last updated: December 6, 2007
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• CMD-193

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity, Adverse Event
Secondary	Pharmacokinetics parameters, Tumor assessment