Study of Talabostat and Cisplatin in Advanced Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	May 14, 2004
Last Updated Date	June 7, 2007
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00083252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Talabostat and Cisplatin in Advanced Melanoma
Official Title ^ICMJE
Brief Summary	The purpose of this study is to assess the antitumor activity and safety of the combination of talabostat and cisplatin in patients with metastatic melanoma.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma Skin Cancer
Intervention ^ICMJE	Drug: talabostat (PT-100) tablets Drug: cisplatin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 metastatic 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 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00083252
Responsible Party
Study ID Numbers ^ICMJE	PTH-303
Study Sponsor ^ICMJE	Point Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Point Therapeutics
Verification Date	June 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP