Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

Neoplasms Clinical Trial

Official title:

A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161642
• Other study ID #: 3152K1-100
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2005
• Last updated: September 9, 2009
• Start date: November 2004
• Est. completion date: July 2007

Study information

• Verified date: September 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 tumors will also be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• CMD-193

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical examinations
Primary	hematology panels
Primary	ECG
Secondary	Radiographic tumor evaluations
Secondary	blood sampling for pharmacokinetic assessments