Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217646
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2005-09-20
Brief Title:
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia Myelodysplastic Syndromes or Blastic Phase Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of BAY 43-9006 NSC 724772 in Patients With Acute Leukemias Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This randomized phase I trial is studying the side effects and best dose of two different schedules of sorafenib in treating patients with refractory or relapsed acute leukemia myelodysplastic syndromes or blastic phase chronic myelogenous leukemia Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of sorafenib when administered in two different schedules in patients with refractory or relapsed acute leukemia myelodysplastic syndromes or blastic phase chronic myelogenous leukemia
II Determine the dose-limiting toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in these patients II Determine the biologic effect of this drug in these patients
OUTLINE This is a randomized dose-escalation phase I study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sorafenib once or twice daily on days 1-5 8-12 and 15-19
Arm II Patients receive oral sorafenib once or twice daily on days 1-14
In both arms treatment repeats every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete remission or partial remission after 6 months may continue therapy at the discretion of the principal investigator
In both arms cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined 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 10 patients are treated at the MTD
I Determine the maximum tolerated dose of sorafenib when administered in two different schedules in patients with refractory or relapsed acute leukemia myelodysplastic syndromes or blastic phase chronic myelogenous leukemia
II Determine the dose-limiting toxicity of this drug in these patients
SECONDARY OBJECTIVES
I Determine the clinical activity of this drug in these patients II Determine the biologic effect of this drug in these patients
OUTLINE This is a randomized dose-escalation phase I study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sorafenib once or twice daily on days 1-5 8-12 and 15-19
Arm II Patients receive oral sorafenib once or twice daily on days 1-14
In both arms treatment repeats every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity Patients achieving complete remission or partial remission after 6 months may continue therapy at the discretion of the principal investigator
In both arms cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined 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 10 patients are treated at the MTD
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 | CTEP | httpsreporternihgovquickSearchU01CA062461 |
| NCI-2009-00081 | REGISTRY | None | None |
| CDR0000442847 | None | None | None |
| 2004-0702 | OTHER | None | None |
| 6742 | OTHER | None | None |
| P30CA016672 | NIH | None | None |