Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
- Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in
patients with advanced solid malignant tumors.
- Assess the toxicity of this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of MS-209.
Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course. On day 1 of the 2nd
course, patients receive MS-209 orally followed by docetaxel IV over 1 hour. Treatment is
repeated every 3 weeks for 4-7 courses (including course with docetaxel alone). Treatment
continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients
experience dose limiting toxicities.
Patients are followed every 6 weeks.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Primary Purpose: Treatment
Veronique Dieras, MD
United States: Federal Government