Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006213
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-09-11
Brief Title:
BMS-214662 in Treating Patients With Acute Leukemia Myelodysplastic Syndrome or Chronic Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 NSC 710086 in Acute Leukemias Myelodysplastic Syndromes RAEB and RAEB-T and Chronic Myeloid Leukemia in Blast Phase
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Phase I trial to study the effectiveness of BMS-214662 in treating patients who have acute leukemia myelodysplastic syndrome or chronic myeloid leukemia in blast phase
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients with acute leukemia myelodysplastic syndrome or chronic myeloid leukemia in blast phase
II Determine any preliminary evidence of antileukemia activity of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 10 months
I Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients with acute leukemia myelodysplastic syndrome or chronic myeloid leukemia in blast phase
II Determine any preliminary evidence of antileukemia activity of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study within 10 months
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 |
|---|---|---|---|
| U01CA062461 | NIH | None | None |
| CDR0000067887 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |
| DM99-290 | None | None | None |