Phase II study of TH-302 in advanced melanoma

Phase: 
II

A Phase 2 Biomarker-Enriched Study of TH-302 in Subjects with Advanced Melanoma

The primary purpose of this research study is to gather information on the safety and effect of TH-302 on your cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about your specific cancer such as the level of oxygen that is present. These data may help to predict in the future which patients with advanced melanoma may be more likely to benefit from TH-302. This research is being done because there are currently no other effective treatments for advanced melanoma of the skin which has recurred or has spread to other parts of the body.

Are you Eligible? (Inclusion Criteria)

1. At least 18 years of age

2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the Investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC)

3. Histologically documented cutaneous malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means

4. Adequate tumor tissue (>0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumor be made available for assessment of potential biomarkers

5. Ability and availability to complete all prescribed biomarker studies

Specialty Area(s)

Trial Location

West 168th Street
New York, NY 10032
United States