Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00161642

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

54

Starts

2004-11-01

Expected to finish

2007-07-01

Last updated by the study team

2009-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Lebanon, New Hampshire, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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