Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

Wyeth

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: CMD-193

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161642

3152K1-100

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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