Study of Talabostat in Advanced Melanoma
1 other identifier
interventional
N/A
1 country
6
Brief Summary
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2004
CompletedFirst Posted
Study publicly available on registry
May 18, 2004
CompletedJune 8, 2007
June 1, 2007
May 14, 2004
June 7, 2007
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322-1013, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Michigan
Ann Arbor, Michigan, 48109-0473, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2004
First Posted
May 18, 2004
Last Updated
June 8, 2007
Record last verified: 2007-06