Study of Talabostat and Cisplatin in Advanced Melanoma

Point Therapeutics

Status and phase

Completed

Phase 2

Conditions

Melanoma

Skin Cancer

Treatments

Drug: cisplatin

Drug: talabostat (PT-100) tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00083252

PTH-303

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.