Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077077
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2004-02-10
Brief Title:
DJ-927 and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase I Study Of The Combination Of Oral DJ-927 And Capecitabine In Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WSU-085503MP4F | None | None | None |
| DAIICHI-927A-PRT006 | None | None | None |