Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516828
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2007-08-14
Brief Title:
Sorafenib and Low Dose Cytarabine in Older Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Sorafenib BAY 43-9006 in Combination With Low Dose ARA-C CYTARABINE in Elderly Patients With AML or High-Risk MDS
Status:
COMPLETED
Status Verified Date:
2020-04
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:
RATIONALE Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer Drugs used in chemotherapy such as cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving sorafenib together with cytarabine may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome
PURPOSE This phase III trial is studying the side effects and best dose of giving sorafenib together with cytarabine and to see how well it works in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome
Detailed Description:
OBJECTIVES
To determine the recommended dose of sorafenib tosylate and cytarabine when given in combination to elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndromes who are not suitable for intensive chemotherapy Phase I
To determine the safety tolerability toxicity profile and dose-limiting toxicities in patients treated with this regimen Phase I
To estimate the efficacy as measured by complete response rate in patients treated with this regimen Phase II
To describe the toxic effects and overall response rate complete and partial in patients treated with this regimen Phase II
To evaluate potential correlates of response in translational research studies including FLT-3 internal tandem duplications and point mutations in blasts Phase II
OUTLINE This is a multicenter study
Phase I Patients receive oral sorafenib tosylate twice daily on days 2-28 and cytarabine subcutaneously twice daily on days 1-10 at the dose level assigned at registration Doses of both drugs will be escalated and the recommended doses for the combination will be determined Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who respond to treatment will receive 2 cycles after response criteria are met
Phase II Patients receive sorafenib tosylate and cytarabine as in phase I at the recommended doses for the combination determined in phase I
Bone marrow or blood samples are collected at baseline and at the end of each course of study treatment Baseline samples are analyzed for mutational status of FLT-3 ie internal tandem duplication ITD and point mutations
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter until progression and toxicities resolve
To determine the recommended dose of sorafenib tosylate and cytarabine when given in combination to elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndromes who are not suitable for intensive chemotherapy Phase I
To determine the safety tolerability toxicity profile and dose-limiting toxicities in patients treated with this regimen Phase I
To estimate the efficacy as measured by complete response rate in patients treated with this regimen Phase II
To describe the toxic effects and overall response rate complete and partial in patients treated with this regimen Phase II
To evaluate potential correlates of response in translational research studies including FLT-3 internal tandem duplications and point mutations in blasts Phase II
OUTLINE This is a multicenter study
Phase I Patients receive oral sorafenib tosylate twice daily on days 2-28 and cytarabine subcutaneously twice daily on days 1-10 at the dose level assigned at registration Doses of both drugs will be escalated and the recommended doses for the combination will be determined Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who respond to treatment will receive 2 cycles after response criteria are met
Phase II Patients receive sorafenib tosylate and cytarabine as in phase I at the recommended doses for the combination determined in phase I
Bone marrow or blood samples are collected at baseline and at the end of each course of study treatment Baseline samples are analyzed for mutational status of FLT-3 ie internal tandem duplication ITD and point mutations
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter until progression and toxicities resolve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000560975 | OTHER | PDQ | None |
| CAN-NCIC-IND186 | REGISTRY | None | None |