Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053794
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2003-02-05
Brief Title:
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue Sarcoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of Perifosine D-21266 In Patients With Previously Untreated Metastatic Or Locally Advanced Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma
PURPOSE Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or locally advanced soft tissue sarcoma
Detailed Description:
OBJECTIVES
Determine the efficacy of perifosine in terms of response rate and duration of response in patients with untreated metastatic or locally advanced soft tissue sarcoma
Determine the toxicity of this drug in these patients
Determine the early progression rate in patients treated with this drug
OUTLINE This is a non-randomized non-blinded multicenter study
Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course For all subsequent courses patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 1 month Patients with stable or responsive disease are followed every 3 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Determine the efficacy of perifosine in terms of response rate and duration of response in patients with untreated metastatic or locally advanced soft tissue sarcoma
Determine the toxicity of this drug in these patients
Determine the early progression rate in patients treated with this drug
OUTLINE This is a non-randomized non-blinded multicenter study
Patients receive a loading dose of oral perifosine twice on day 1 and then once daily on days 2-21 for the first course For all subsequent courses patients receive a loading dose of oral perifosine once on day 1 and then once daily on days 2-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 1 month Patients with stable or responsive disease are followed every 3 months thereafter
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000269476 | OTHER | PDQ | None |
| CAN-NCIC-IND155 | OTHER | None | None |