Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020579
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2001-07-11
Brief Title:
MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of an Oral Histone Deacetylase Inhibitor MS-275 in Refractory Solid Tumors and Lymphomas
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth
PURPOSE This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 in patients with advanced solid tumors or lymphomas
Determine the profile of adverse events including changes in laboratory parameters in patients treated with this drug
Assess the pharmacology and pharmacokinetics of this drug in these patients
Design MS-275 regimens with possibly more frequent dose administration based on the pharmacology of MS-275 using the schedule in this study
Determine the antineoplastic activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral MS-275 once on day 1 Courses repeat every 2 weeks every 2-week schedule Alternatively patients receive oral MS-275 once on days 1 8 15 and 22 weekly schedule Courses repeat every 6 weeks Treatment for both schedules continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 on the every 2-week schedule until the maximum tolerated dose MTD is determined Once the MTD for the every 2-week schedule is determined patients receive treatment on the weekly schedule as above The MTD is then determined for the weekly schedule The MTD for both schedules is defined as the dose preceding that at which at least 2 of up to 6 patients experience dose-limiting toxicity Once the MTD is determined for the weekly schedule up to 3 additional patients are accrued to receive MS-275 at the MTD of the weekly schedule
Disease status is assessed every 3 months
PROJECTED ACCRUAL A total of 50-75 patients will be accrued for this study
Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 in patients with advanced solid tumors or lymphomas
Determine the profile of adverse events including changes in laboratory parameters in patients treated with this drug
Assess the pharmacology and pharmacokinetics of this drug in these patients
Design MS-275 regimens with possibly more frequent dose administration based on the pharmacology of MS-275 using the schedule in this study
Determine the antineoplastic activity of this drug in these patients
OUTLINE This is an open-label dose-escalation study
Patients receive oral MS-275 once on day 1 Courses repeat every 2 weeks every 2-week schedule Alternatively patients receive oral MS-275 once on days 1 8 15 and 22 weekly schedule Courses repeat every 6 weeks Treatment for both schedules continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 on the every 2-week schedule until the maximum tolerated dose MTD is determined Once the MTD for the every 2-week schedule is determined patients receive treatment on the weekly schedule as above The MTD is then determined for the weekly schedule The MTD for both schedules is defined as the dose preceding that at which at least 2 of up to 6 patients experience dose-limiting toxicity Once the MTD is determined for the weekly schedule up to 3 additional patients are accrued to receive MS-275 at the MTD of the weekly schedule
Disease status is assessed every 3 months
PROJECTED ACCRUAL A total of 50-75 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 |
|---|---|---|---|
| CDR0000068615 | None | None | None |
| 01-C-0124 | None | None | None |
| NCI-2792 | None | None | None |