Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080834
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2004-04-07
Brief Title:
DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
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 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma cancer
PURPOSE This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma cancer
Detailed Description:
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
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
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 |
|---|---|---|---|
| DAIICHI-927A-PRT004 | None | None | None |
| MDA-2003-0749 | None | None | None |