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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
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 21, 2013