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Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00161642
First received: September 7, 2005
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected.


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: A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant 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:
  • Physical examinations
  • hematology panels
  • ECG

Secondary Outcome Measures:
  • Radiographic tumor evaluations
  • blood sampling for pharmacokinetic assessments

Enrollment: 54
Study Start Date: November 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
  • Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
  • Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to the first dose of CMD-193.
  • Significant prior allergic reaction to recombinant human or murine proteins
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161642

Locations
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Nashville, Tennessee, United States, 37203
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: NCT00161642     History of Changes
Other Study ID Numbers: 3152K1-100
Study First Received: September 7, 2005
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013