Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064324
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2003-07-08
Brief Title:
Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Perifosine in Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of perifosine in treating patients who have advanced soft tissue sarcoma Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma
SECONDARY OBJECTIVES
I To evaluate survival and time to progression II To evaluate objective tumor response status and duration III To evaluate adverse event rates IV To evaluate patterns of treatment failure V To evaluate pharmacokinetics
OUTLINE This is a multicenter study
Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only For all subsequent courses patients receive oral perifosine once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 17-46 patients will be accrued for this study within 9-12 months
I To evaluate the 6-month progression-free rate in patients treated with perifosine and having advanced soft tissue sarcoma
SECONDARY OBJECTIVES
I To evaluate survival and time to progression II To evaluate objective tumor response status and duration III To evaluate adverse event rates IV To evaluate patterns of treatment failure V To evaluate pharmacokinetics
OUTLINE This is a multicenter study
Patients receive a loading dose of oral perifosine every 6 hours for a total of 4 doses on day 1 and once daily on days 2-28 of course 1 only For all subsequent courses patients receive oral perifosine once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 17-46 patients will be accrued for this study within 9-12 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 |
|---|---|---|---|
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |
| MC0276 | None | None | None |
| 5972 | None | None | None |