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Study of Talabostat in Advanced Melanoma

Primary Purpose

Melanoma, Skin Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
talabostat (PT-100) tablets
Sponsored by
Point Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University/Winship Cancer Institute
  • University of Chicago
  • University of Michigan
  • Dartmouth-Hitchcock Medical Center
  • University of Pittsburgh
  • Mary Crowley Medical Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 14, 2004
Last Updated
June 7, 2007
Sponsor
Point Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00083239
Brief Title
Study of Talabostat in Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Point Therapeutics

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Skin Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
talabostat (PT-100) tablets

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0473
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2582
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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Study of Talabostat in Advanced Melanoma

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