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 objective tumor response rate in patients with progressive locally advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as second-line treatment. Secondary * Determine the duration of response in patients treated with this drug. * Determine the time to tumor progression in patients treated with this drug. * Determine the median survival time in patients treated with this drug. * Determine the quantitative and qualitative toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing). Patients receive oral DJ-927\* on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive 1 of 2 selected doses to confirm the previously established maximum tolerated dose Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
