Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399789
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2006-11-13
Brief Title:
A Phase 12 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
A Phase 12 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
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 study of the drug perifosine that consists of 2 parts The first part of this study was designed to determine the highest dose of perifosine that can be administered to people every week without severe or prolonged nausea vomiting and diarrhea This study started with patients taking 900 mgweek and went up to 1800 mgweek Part I of this study is completed The MTD had been determined and incorporated in Part II
The goals in Part II are to
1 Compare the gastrointestinal toxicity of 3 different dose-schedules and
2 Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer
The goals in Part II are to
1 Compare the gastrointestinal toxicity of 3 different dose-schedules and
2 Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer
Detailed Description:
The primary purpose of Part I of this study was to determine the maximum dose of perifosine that can be administered with tolerable gastrointestinal toxicity and to obtain preliminary information on the response rate of perifosine in non-small cell lung cancer In addition the trial was and is designed to provide some insight into the nature of the anti-tumor effect the time to response and dose-schedules that should be used in future trials
Part 2 - In the second part of this study patients will be randomized to one of 3 dose-schedules of perifosine and to test if the response rate of perifosine in non small cell lung cancer is 10 in any of the 3 arms of the study The study is not designed to compare the response rates in the 3 arms of the trial but toxicities will be compared The regimens are
A weekly dose of 900 mg to be divided into three doses of 300 mg each If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 1200 mg divided into four doses of 300 mg
A daily dose of 150 mg to be divided into three doses of 50 mg each If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 200 mg divided into four doses of 50 mg
A daily dose of 150 mg to be given in one dose at bedtime If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 200 mg to be given in one dose at bedtime
Patients receiving weekly perifosine will receive prophylactic antiemetics Patients receiving daily perifosine will not routinely receive prophylactic antiemetics unless they experience nausea 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
Part 2 - In the second part of this study patients will be randomized to one of 3 dose-schedules of perifosine and to test if the response rate of perifosine in non small cell lung cancer is 10 in any of the 3 arms of the study The study is not designed to compare the response rates in the 3 arms of the trial but toxicities will be compared The regimens are
A weekly dose of 900 mg to be divided into three doses of 300 mg each If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 1200 mg divided into four doses of 300 mg
A daily dose of 150 mg to be divided into three doses of 50 mg each If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 200 mg divided into four doses of 50 mg
A daily dose of 150 mg to be given in one dose at bedtime If patients experience no grade 2 toxicities during their first month of therapy the dose will be escalated to 200 mg to be given in one dose at bedtime
Patients receiving weekly perifosine will receive prophylactic antiemetics Patients receiving daily perifosine will not routinely receive prophylactic antiemetics unless they experience nausea 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
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