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Sponsored by: |
GPC Biotech |
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Information provided by: | GPC Biotech |
ClinicalTrials.gov Identifier: | NCT00329329 |
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced solid malignancies.
Condition | Intervention | Phase |
---|---|---|
Malignancies |
Drug: Satraplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies |
Estimated Enrollment: | 24 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Adequate organ function as defined by the following:
Key Exclusion Criteria:
Patients who have not recovered (> grade 1) from the following toxicities of previous regimens before enrollment:
Contact: Faith Nathan | 609-524-1027 |
United States, Illinois | |
Northwestern University Medical Center | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: William Gradishar, MD 312-695-4541 w-gradishar@northwestern.edu |
Principal Investigator: | William Gradishar, MD | Northwestern University Medical Center |
Study ID Numbers: | SAT1-05-02 |
Study First Received: | May 22, 2006 |
Last Updated: | August 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00329329 |
Health Authority: | United States: Food and Drug Administration |
Advanced solid malignancies |
Satraplatin Capecitabine |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |