Study of Talabostat in Advanced Melanoma

This study has been completed.
Sponsor:
Information provided by:
Point Therapeutics
ClinicalTrials.gov Identifier:
NCT00083239
First received: May 14, 2004
Last updated: June 7, 2007
Last verified: June 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Point Therapeutics:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00083239     History of Changes
Other Study ID Numbers: PTH-301
Study First Received: May 14, 2004
Last Updated: June 7, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014