Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131989
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2005-08-16
Brief Title:
Sorafenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Dose Escalation Trial of the Raf Kinase Inhibitor BAY 43-9006 NSC 724772 as Single Agent for Adults With Relapsed and Refractory Acute Leukemias and Chronic Myeloid Leukemia in Blast Crisis
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:
This phase I trial is studying the side effects and best dose of sorafenib in treating patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia or 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 To determine the dose-limiting toxicitys DLTs and maximally tolerated dose MTD of BAY 43-9006 given orally
SECONDARY OBJECTIVES
I To obtain preliminary evidence of tumor response to BAY 43-9006 in patients II To assess the pharmacokinetic profile of BAY 43-9006 III To characterize the preliminary profile of adverse events and changes in laboratory parameters in patients treated with BAY 43-9006
IV To assess effects of BAY 43-9006 on various cellular properties of leukemic blasts exposed to drug in vivo and in vitro
OUTLINE This is an open-label dose-escalation study
Patients receive oral sorafenib twice daily on days 1-14 or 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR may be considered for retreatment with sorafenib for up to an additional 6 courses upon disease recurrence provided the duration of CR is longer than 1 month
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 which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 12 patients are treated at the MTD
After completion of study treatment patients are followed monthly for up to 1 year
I To determine the dose-limiting toxicitys DLTs and maximally tolerated dose MTD of BAY 43-9006 given orally
SECONDARY OBJECTIVES
I To obtain preliminary evidence of tumor response to BAY 43-9006 in patients II To assess the pharmacokinetic profile of BAY 43-9006 III To characterize the preliminary profile of adverse events and changes in laboratory parameters in patients treated with BAY 43-9006
IV To assess effects of BAY 43-9006 on various cellular properties of leukemic blasts exposed to drug in vivo and in vitro
OUTLINE This is an open-label dose-escalation study
Patients receive oral sorafenib twice daily on days 1-14 or 1-21 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR may be considered for retreatment with sorafenib for up to an additional 6 courses upon disease recurrence provided the duration of CR is longer than 1 month
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 which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity A total of 12 patients are treated at the MTD
After completion of study treatment patients are followed monthly for up to 1 year
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 |
|---|---|---|---|
| U01CA070095 | NIH | None | httpsreporternihgovquickSearchU01CA070095 |
| J-0509 | None | None | None |