Status:

COMPLETED

Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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 tu...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT00161642

Start Date

November 1 2004

End Date

July 1 2007

Last Update

September 10 2009

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Lebanon, New Hampshire, United States, 03756

2

Philadelphia, Pennsylvania, United States, 19111

3

Nashville, Tennessee, United States, 37203