Study of Talabostat in Advanced Melanoma

Point Therapeutics12 个研究点分布在 1 个国家开始时间: 2004年5月18日最近更新: 2007年6月8日

适应症

试验速览

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

•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

•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.

发起方

Point Therapeutics

申办方类型

Industry

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