Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Daiichi Sankyo
OBJECTIVES: Primary * 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 these patients. Secondary * 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 days 2-15. * 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 toxicity. 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 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
