Study Evaluating CMD-193 in Advanced Malignant Solid Tumors - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00161642

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Physical examinations
hematology panels
ECG

Secondary Outcome Measures:

Radiographic tumor evaluations
blood sampling for pharmacokinetic assessments

Estimated Enrollment:	68
Study Start Date:	November 2004

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3152K1-100
Study First Received:	September 7, 2005
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00161642
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Malignant Tumors

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009