Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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talabostat (PT-100) tablets
cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Point Therapeutics
INDUSTRY
Locations
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University of Arkansas Medical Sciences
Little Rock, Arkansas, United States
Cancer Institute Medical Group, Inc.
Santa Monica, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Cancer Center of Florida
Ocoee, Florida, United States
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, United States
New Mexico Cancer Center Alliance
Albuquerque, New Mexico, United States
NYU School of Medicine
New York, New York, United States
Fifth Avenue Medical Healthcare
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Cancer Center of the Carolinas
Greenville, South Carolina, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Care Northwest Research
Spokane, Washington, United States
Countries
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Other Identifiers
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PTH-303
Identifier Type: -
Identifier Source: org_study_id