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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00257881
First received: November 22, 2005
Last updated: December 6, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: CMD-193
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Dose Limiting Toxicity, Adverse Event

Secondary Outcome Measures:
  • Pharmacokinetics parameters, Tumor assessment

Estimated Enrollment: 46
Study Start Date: November 2005
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257881

Locations
Japan
Tokyo, Chuo-ku, Japan, 104-0045
Nagaizumi-cho, Sunto-gun, Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00257881     History of Changes
Other Study ID Numbers: 3152K1-101
Study First Received: November 22, 2005
Last Updated: December 6, 2007
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014