NCT00077077

DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as DJ-927 and capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of DJ-927 and capecitabine in treating patients with locally advanced or metastatic solid tumors.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	DJ-927
DRUG	capecitabine

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2004-02-11
• Last updated: 2012-05-16

Locations

3 sites across 1 country: United States