Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398697
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2006-11-10
Brief Title:
Phase I Perifosine and Gemcitabine Study
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
Phase 1 Trial of the Combination of Perifosine and Gemcitabine
Status:
COMPLETED
Status Verified Date:
2007-01
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 in combination with Gemcitabine Perifosine is an oral anti-cancer agent that has been used in more than 140 people but has not been combined with other drugs before this study The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen without severe or prolonged nausea vomiting and diarrhea This study starts with patients taking 50 mgday and goes up to 150 mgday After the highest tolerable dose is found we will add 10 more patients at that dose
Detailed Description:
This is a phase 1 open-label trial of perifosine and gemcitabine in patients with malignancies for whom single agent gemcitabine is a reasonable treatment option All patients will receive gemcitabine at a dose of 1000 mgm2 on days 1 and 8 of a 21-day cycle Patients will receive perifosine orally at a dose of 50 100 or 150 mg per day for the first 14 days of the 21-day cycle Cohorts of 3 patients will be treated with doses of 50 mg administered either once twice or three times a day In this study a maximum tolerated dose MTD will be defined as a dose that can be given without grade 34 non-hematologic toxicity in more than 13 patients If 23 patients in any cohort encounter a grade 34 non-hematologic toxicity an additional 3 patients will be added If the dose is intolerable for 36 patients then the previous level will be declared the MTD Once an MTD has been determined an additional 10 patients will be added at the MTD to better define the expected toxicities
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