Study of Satraplatin (JM-216) in Combination With Docetaxel

Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Inclusion Criteria:

• Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
• Life expectancy of at least 3 months
• Measurable or evaluable disease
• ECOG performance status of <= 2
• Willingness and ability to give informed consent

Exclusion Criteria:

• Women who are pregnant or breastfeeding
• Other chemotherapy treatment less than 4 weeks prior to enrollment
• Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational