Study of Talabostat and Cisplatin in Advanced Melanoma

Melanoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083252
• Other study ID #: PTH-303
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: June 7, 2007

Study information

• Verified date: June 2007
• Source: Point Therapeutics
• 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 assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed melanoma that is metastatic (unresectable Stage IV per AJCC 2002)

• Patients with measurable disease defined as at least one measurable index lesion with clearly defined margins

• ECOG Performance Status of 0, 1, or 2

• Expected survival =12 weeks

• Written informed consent

Exclusion Criteria:

• More than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma

• Radiation therapy to >50% of the bone marrow. Patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation.

• Clinically significant laboratory abnormalities

• Symptomatic CNS metastases

• Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix

• The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy

• Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol

• Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. Patients must have recovered from all of the side effects of treatment in order to be enrolled.

• Pregnant or lactating women.

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Skin Cancer

Intervention

Drug:
• talabostat (PT-100) tablets

• cisplatin

Locations

Country	Name	City	State
United States	New Mexico Cancer Center Alliance	Albuquerque	New Mexico
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Indiana Hematology Oncology Consultants	Indianapolis	Indiana
United States	University of Arkansas Medical Sciences	Little Rock	Arkansas
United States	Fifth Avenue Medical Healthcare	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Cancer Center of Florida	Ocoee	Florida
United States	Cancer Institute Medical Group, Inc.	Santa Monica	California
United States	Cancer Care Northwest Research	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Point Therapeutics

Country where clinical trial is conducted

United States,