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Study of Talabostat and Cisplatin in Advanced Melanoma

Primary Purpose

Melanoma, Skin Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
talabostat (PT-100) tablets
cisplatin
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 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.

Sites / Locations

  • University of Arkansas Medical Sciences
  • Cancer Institute Medical Group, Inc.
  • University of Colorado Health Sciences Center
  • Cancer Center of Florida
  • Indiana Hematology Oncology Consultants
  • New Mexico Cancer Center Alliance
  • NYU School of Medicine
  • Fifth Avenue Medical Healthcare
  • Carolinas Medical Center
  • Cancer Center of the Carolinas
  • Mary Crowley Medical Research Center
  • Tyler Cancer Center
  • Cancer Care Northwest Research

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
NCT00083252
Brief Title
Study of Talabostat and Cisplatin 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 the combination of talabostat and cisplatin 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
Intervention Type
Drug
Intervention Name(s)
cisplatin

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 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.
Facility Information:
Facility Name
University of Arkansas Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cancer Institute Medical Group, Inc.
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cancer Center of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Indiana Hematology Oncology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
New Mexico Cancer Center Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Fifth Avenue Medical Healthcare
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Care Northwest Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Talabostat and Cisplatin in Advanced Melanoma

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