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Study of Talabostat and Cisplatin in Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083252
Recruitment Status : Completed
First Posted : May 18, 2004
Last Update Posted : June 8, 2007
Information provided by:
Point Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Skin Cancer Drug: talabostat (PT-100) tablets Drug: cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Cisplatin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00083252

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United States, Arkansas
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Cancer Institute Medical Group, Inc.
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Cancer Center of Florida
Ocoee, Florida, United States, 34761
United States, Indiana
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, United States, 46202
United States, New Mexico
New Mexico Cancer Center Alliance
Albuquerque, New Mexico, United States, 87106
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Fifth Avenue Medical Healthcare
New York, New York, United States, 10128
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Cancer Care Northwest Research
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Point Therapeutics
Layout table for additonal information Identifier: NCT00083252    
Other Study ID Numbers: PTH-303
First Posted: May 18, 2004    Key Record Dates
Last Update Posted: June 8, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases
Antineoplastic Agents