Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401388
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2006-11-17
Brief Title:
A Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
Sarcoma Alliance for Research Through Collaboration SARC Multicenter Trial A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas
Status:
COMPLETED
Status Verified Date:
2012-02
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 is a phase II study of perifosine in patients with chondrosarcomas alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas Patients will receive perifosine 100 mg orally qhs with food until disease progression The goals of this study include
In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas
Response to therapy will be based on regression of measurable disease according to Choi criteria Time to progression and duration of stable disease will be measured as secondary endpoints of the study
In this study a daily dose of perifosine previously determined to be relatively non-toxic will be evaluated in patients with chondrosarcomas alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas
Response to therapy will be based on regression of measurable disease according to Choi criteria Time to progression and duration of stable disease will be measured as secondary endpoints of the study
Detailed Description:
This is a phase II study of perifosine in patients with chondrosarcomas alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas Patients will receive perifosine 100 mg orally qhs with food until disease progression
Perifosine is available in 50 mg tablets Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients Patients may need anti-emetics andor anti-diarrheals All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart Patients who experience toxicity may continue on treatment with doses delayed or reduced Evaluation of all lesions for progression or response will be made at 3-month intervals
STUDY KEY POINTS
Treatment will be administered on an outpatient basis in 28-day cycles
Growth factors should not be needed however use by patients on this trial is NOT prohibited
A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer
Perifosine is available in 50 mg tablets Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients Patients may need anti-emetics andor anti-diarrheals All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart Patients who experience toxicity may continue on treatment with doses delayed or reduced Evaluation of all lesions for progression or response will be made at 3-month intervals
STUDY KEY POINTS
Treatment will be administered on an outpatient basis in 28-day cycles
Growth factors should not be needed however use by patients on this trial is NOT prohibited
A favorable outcome will be defined as a complete or partial response according to the Choi criteria or stable disease by the Choi criteria for 6 months or longer
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