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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00257881
Recruitment Status : Terminated
First Posted : November 23, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: CMD-193 Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors
Study Start Date : November 2005
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. Dose Limiting Toxicity, Adverse Event

Secondary Outcome Measures :
  1. Pharmacokinetics parameters, Tumor assessment


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257881


Locations
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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
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

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ClinicalTrials.gov Identifier: NCT00257881     History of Changes
Other Study ID Numbers: 3152K1-101
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: December 10, 2007
Last Verified: December 2007

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