Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399152
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2006-11-09
Brief Title:
Perifosine Sunitinib Malate for Patients With Advanced Cancers
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sunitinib Malate for Patients With Advanced Cancers
Status:
COMPLETED
Status Verified Date:
2011-11
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:
This study is a Phase I trial in two parts In part 1 a MTD to the combination of perifosine and sunitinib malate will be determined In part 2 with the MTD as a starting point a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least two courses of therapy which would make them evaluable for response in a Phase II study
Detailed Description:
This study is a Phase I trial in two parts In part 1 an MTD to the combination of perifosine and sunitinib malate will be determined In some previous trials with perifosine and other biologic agents doses determined in Phase I studies are not as well tolerated in larger groups of patients when response is an endpoint Thus in part 2 with the MTD as a starting point a group of patients will be accrued with the goal of ensuring that they will be able to tolerate at least two courses of therapy which would make them evaluable for response in a Phase II study As a secondary endpoint the effects of the combination of perifosine and sunitinib malate will be evaluated for response rate and time to progression The pharmacokinetics of the combination of the study drugs will be measured
For the purposes of this study one cycle of therapy will be defined as 6 weeks Patients will take one 50 mg tablet of perifosine one to three times a day and sunitinib malate once a day for 4 out of 6 weeks Patients may need anti-emetics andor anti-diarrheals Patients will be evaluated for progression or response at 12-week intervals
Patients who experience toxicity may continue on treatment with doses delayed or reduced
All patients should continue therapy unless disease progression is documented on two occasions at least four weeks apart
Part 1 of this Phase I study will accrue from six to 24 patients depending on the number of dose levels evaluated Up to six patients will be treated at each dose level A dose limiting toxicity DLT will be defined as
Grade 3 or greater non-hematologic toxicity
Grade 4 hematologic toxicity
For the purposes of this study one cycle of therapy will be defined as 6 weeks Patients will take one 50 mg tablet of perifosine one to three times a day and sunitinib malate once a day for 4 out of 6 weeks Patients may need anti-emetics andor anti-diarrheals Patients will be evaluated for progression or response at 12-week intervals
Patients who experience toxicity may continue on treatment with doses delayed or reduced
All patients should continue therapy unless disease progression is documented on two occasions at least four weeks apart
Part 1 of this Phase I study will accrue from six to 24 patients depending on the number of dose levels evaluated Up to six patients will be treated at each dose level A dose limiting toxicity DLT will be defined as
Grade 3 or greater non-hematologic toxicity
Grade 4 hematologic toxicity
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