Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
This is a single center, open-label, non-randomized, Phase I dose finding study of the
investigational, oral cytotoxic drug, satraplatin in combination with capecitabine 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
William Gradishar, MD
Northwestern University Medical Center
United States: Food and Drug Administration
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