- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083239
Study of Talabostat in Advanced Melanoma
June 7, 2007 updated by: Point Therapeutics
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322-1013
- Emory University/Winship Cancer Institute
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Michigan
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Ann Arbor, Michigan, United States, 48109-0473
- University of Michigan
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0001
- Dartmouth-Hitchcock Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213-2582
- University of Pittsburgh
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Texas
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Dallas, Texas, United States, 75246
- Mary Crowley Medical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 7, 2022
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
May 14, 2004
First Submitted That Met QC Criteria
May 17, 2004
First Posted (Estimate)
May 18, 2004
Study Record Updates
Last Update Posted (Estimate)
June 8, 2007
Last Update Submitted That Met QC Criteria
June 7, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTH-301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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