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Study of Talabostat in Advanced Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00083239
First Posted: May 18, 2004
Last Update Posted: June 8, 2007
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.
Information provided by:
Point Therapeutics
  Purpose
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.

Condition Intervention Phase
Melanoma Skin Cancer Drug: talabostat (PT-100) tablets Phase 2

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

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

  Eligibility

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.


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

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 Stage IV 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
  • 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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00083239


Locations
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322-1013
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0473
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Point Therapeutics
  More Information

ClinicalTrials.gov Identifier: NCT00083239     History of Changes
Other Study ID Numbers: PTH-301
First Submitted: May 14, 2004
First Posted: May 18, 2004
Last Update Posted: June 8, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases