Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101179
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2005-01-07
Brief Title:
MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia or Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose-Finding Trial of the Histone Deacetylase Inhibitor MS-275 NSC 706995 in Combination With 5-Azacitidine 5AC NSC 102816 in Patients With Myelodysplastic Syndromes MDS Chronic Myelomonocytic Leukemia CMMoL and Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2019-10
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:
MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as azacitidine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving MS-275 together with azacitidine may kill more cancer cells This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes chronic myelomonocytic leukemia or acute myeloid leukemia
Detailed Description:
OBJECTIVES
I Determine the safety and toxicity of MS-275 and azacitidine in patients with myelodysplastic syndromes chronic myelomonocytic leukemia or acute myeloid leukemia
II Determine the maximum tolerated dose and optimal phase II dose of MS-275 when combined with azacitidine in these patients
III Determine preliminarily the potential therapeutic activity of this regimen in these patients
IV Correlate MS-275 pharmacokinetics with clinical response and laboratory correlative endpoints in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of MS-275 Patients receive azacitidine subcutaneously on days 1-10 and oral MS-275 on days 3 and 10
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined Patients receive adjusted doses of azacitidine based on clinical response The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 9 additional patients are treated at the MTD
Note Patients who do not achieve hematologic improvement or partial or complete response but who have stable disease after 4 courses of therapy may receive an additional 4 courses of therapy at a higher dose than what was originally assigned
I Determine the safety and toxicity of MS-275 and azacitidine in patients with myelodysplastic syndromes chronic myelomonocytic leukemia or acute myeloid leukemia
II Determine the maximum tolerated dose and optimal phase II dose of MS-275 when combined with azacitidine in these patients
III Determine preliminarily the potential therapeutic activity of this regimen in these patients
IV Correlate MS-275 pharmacokinetics with clinical response and laboratory correlative endpoints in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of MS-275 Patients receive azacitidine subcutaneously on days 1-10 and oral MS-275 on days 3 and 10
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose MTD is determined Patients receive adjusted doses of azacitidine based on clinical response The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 9 additional patients are treated at the MTD
Note Patients who do not achieve hematologic improvement or partial or complete response but who have stable disease after 4 courses of therapy may receive an additional 4 courses of therapy at a higher dose than what was originally assigned
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-2009-00071 | REGISTRY | None | None |
| CDR0000405841 | None | None | None |
| J0443 | None | None | None |
| J0443 | OTHER | None | None |
| 6591 | OTHER | None | None |
| P30CA006973 | NIH | None | None |
| U01CA070095 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070095 |