Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390468
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2006-10-18
Brief Title:
Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Tandutinib MLN518 in Androgen-Independent Prostate Cancer With Bone Metastases
Status:
COMPLETED
Status Verified Date:
2013-01
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 Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases
PURPOSE This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases
Detailed Description:
OBJECTIVES
Primary
Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib
Secondary
Determine the prostate-specific antigen PSA decline rate by 50 PSA response using the PSA Working Group Criteria in patients treated with this regimen
Evaluate modulation of bone pain and bone markers in patients treated with this regimen
Determine the objective tumor response by RECIST Response Evaluation Criteria In Solid Tumors criteria in patients treated with this regimen
Determine the qualitative and quantitative toxicity of this regimen in these patients
OUTLINE Patients receive oral tandutinib twice daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Bone pain is assessed at baseline on day 1 of course 3 and at disease progression
After completion of study treatment patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib
Secondary
Determine the prostate-specific antigen PSA decline rate by 50 PSA response using the PSA Working Group Criteria in patients treated with this regimen
Evaluate modulation of bone pain and bone markers in patients treated with this regimen
Determine the objective tumor response by RECIST Response Evaluation Criteria In Solid Tumors criteria in patients treated with this regimen
Determine the qualitative and quantitative toxicity of this regimen in these patients
OUTLINE Patients receive oral tandutinib twice daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Bone pain is assessed at baseline on day 1 of course 3 and at disease progression
After completion of study treatment patients are followed for 4 weeks
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000504104 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-2005-0717 | OTHER | None | None |
| NCI-7409 | None | None | None |