A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
- Determine the maximum tolerated dose of DJ-927 and capecitabine in patients with
locally advanced or metastatic solid tumors.
- Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in
- Determine the toxicity profile of this regimen in these patients.
- Determine the possible pharmacokinetic interactions of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation, nonrandomized, multicenter study.
- Course 1: Patients receive oral DJ-927 once on day 1 and oral capecitabine once on days
0 and 1 and twice daily on days 2-14.
- Course 2: Patients receive DJ-927 as in course 1 and oral capecitabine twice daily on
- Course 3 and all subsequent courses: Patients receive DJ-927 as in course 1 and oral
capecitabine twice daily on days 1-14.
All courses repeat every 21 days in the absence of disease progression or unacceptable
Cohorts of 3-6 patients receive escalating doses of DJ-927 and capecitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients
receive treatment at the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 18
Masking: Open Label, Primary Purpose: Treatment
Chris H. Takimoto, MD, PhD, FACP
Cancer Therapy and Research Center, Texas
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Comprehensive Cancer Center at University of Alabama at Birmingham||Birmingham, Alabama 35294|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|