Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004886
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2000-03-07
Brief Title:
MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Study to Determine the Safety of MS-209 in Combination With Docetaxel in Patients With a Solid Progressive Tumor
Status:
COMPLETED
Status Verified Date:
2012-09
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of MS 209 plus docetaxel in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors
Assess the toxicity of this regimen in these patients
OUTLINE This is a dose escalation multicenter study of MS-209
Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course On day 1 of the 2nd course patients receive MS-209 orally followed by docetaxel IV over 1 hour Treatment is repeated every 3 weeks for 4-7 courses including course with docetaxel alone Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose limiting toxicities
Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for this study
Determine the maximum tolerated dose of oral MS-209 when given with docetaxel IV in patients with advanced solid malignant tumors
Assess the toxicity of this regimen in these patients
OUTLINE This is a dose escalation multicenter study of MS-209
Patients receive docetaxel IV over 1 hour on day 1 of a 3 week course On day 1 of the 2nd course patients receive MS-209 orally followed by docetaxel IV over 1 hour Treatment is repeated every 3 weeks for 4-7 courses including course with docetaxel alone Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-209 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 3 or 3 of 6 patients experience dose limiting toxicities
Patients are followed every 6 weeks
PROJECTED ACCRUAL Approximately 3-30 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 |
|---|---|---|---|
| EORTC-16992 | None | None | None |