Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003822
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
1999-11-01
Brief Title:
SR-45023A in Treating Patients With Advanced Solid Tumors
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of SR-45023A During a 14-Day Treatment Schedule
Status:
COMPLETED
Status Verified Date:
2001-03
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 I trial to study the effectiveness of SR-45023A in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of SR-45023A in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of SR-45023A in patients with locally advanced or metastatic solid tumors that are refractory or for which no standard therapy exists II Determine the quantitative toxic effects of SR-45023A in these patients III Assess the pharmacokinetic profile of SR-45023A in these patients IV Identify the antitumor activity of SR-45023A in these patients
OUTLINE This is a dose escalation study Patients receive oral SR-45023A twice daily for 14 days followed by 7 days rest On day 14 of course 1 patients receive only one dose of therapy due to pharmacokinetic sampling Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed until death
PROJECTED ACCRUAL Up to 30 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive oral SR-45023A twice daily for 14 days followed by 7 days rest On day 14 of course 1 patients receive only one dose of therapy due to pharmacokinetic sampling Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed until death
PROJECTED ACCRUAL Up to 30 patients will be accrued for this study
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-V99-1532 | None | None | None |
| ILEX-SR101-A9 | None | None | None |
| ILEX-SR101 | None | None | None |
| UARIZ-HSC-98161 | None | None | None |