Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053924
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-02-05
Brief Title:
Perifosine in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase 2 Study Of Perifosine As Second Line Therapy For Advanced Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-07
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 locally advanced or metastatic pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of perifosine in terms of 6-month survival in patients with advanced adenocarcinoma of the pancreas
Determine the safety and tolerability of this drug in these patients
Determine median survival time and the 1-year survival rate of patients treated with this drug
Determine the objective response rate partial and complete response duration and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE Patients receive oral perifosine daily for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 15 months
Determine the efficacy of perifosine in terms of 6-month survival in patients with advanced adenocarcinoma of the pancreas
Determine the safety and tolerability of this drug in these patients
Determine median survival time and the 1-year survival rate of patients treated with this drug
Determine the objective response rate partial and complete response duration and time to progression in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE Patients receive oral perifosine daily for 3 weeks Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| NCI-5983 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000269586 | REGISTRY | None | None |