Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
Phase I Study of BAY 43-9006 (NSC 724772) in Patients With Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
6 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedApril 28, 2015
February 1, 2013
5.2 years
September 20, 2005
April 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
21 days
Study Arms (2)
Arm I
EXPERIMENTALPatients receive oral sorafenib once or twice daily on days 1-5, 8-12, and 15-19.
Arm II
EXPERIMENTALPatients receive oral sorafenib once or twice daily on days 1-14.
Interventions
Given orally
Eligibility Criteria
You may qualify if:
- Diagnosis of 1 of the following: Acute myeloid leukemia (Acute promyelocytic leukemia (M3) allowed provided patient has failed prior therapy with both tretinoin and arsenic alone or in combination); Acute lymphoblastic leukemia; Myelodysplastic syndromes; Blastic phase chronic myelogenous leukemia (Failed OR intolerant to imatinib mesylate)
- Must have failed prior therapy with \>= 1 cytotoxic- or biologic-targeted agent (e.g., hypomethylating agents, farnesyl transferase inhibitors, thalidomide, or tyrosine kinase inhibitors); Any number of prior regimens allowed
- Performance status: ECOG 0-1
- ALT =\< 2.5 times upper limit of normal
- Bilirubin =\< 1.5 mg/dL
- Creatinine =\< 2.0 mg/dL OR Creatinine clearance \>= 60 mL/min
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- Prior bone marrow transplantation allowed
- At least 2 weeks since prior cytotoxic agents OR at least 5 half-lives for non-cytotoxic agents in the absence of rapidly progressing disease
- At least 24 hours since prior hydrea for control of peripheral blood leukemia cell counts
- Hydroxyurea allowed up to 72 hours after start of therapy with sorafenib
- No persistent, chronic, clinically significant toxicities \> grade 1 from prior chemotherapy
You may not qualify if:
- Cytopenias secondary to multilineage bone marrow failure allowed
- Ineligible for or not willing to undergo allogeneic stem cell transplantation OR no donor available
- Absolute blast count=\< 20,000/mm\^3 unless patient has documented fms-like tyrosine kinase 3 internal tandem duplication
- No evidence of bleeding diathesis (except due to low platelets associated with the primary disease)
- No New York Heart Association class III or IV congestive heart failure
- No uncontrolled hypertension (i.e., sustained systolic blood pressure \[BP\] \>= 150 mm Hg or diastolic BP \>= 90 mm Hg)
- No unstable angina pectoris
- No symptomatic cardiac arrhythmia requiring and not responding to medical intervention
- Not pregnant or nursing
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drug
- No swallowing dysfunction that would impede oral ingestion of tablets
- No active uncontrolled infection
- No other uncontrolled illness
- No prior sorafenib
- No other concurrent investigational or commercial agents, except for standard intrathecal chemotherapy for the treatment of isolated CNS leukemic involvement
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Borthakur G, Kantarjian H, Ravandi F, Zhang W, Konopleva M, Wright JJ, Faderl S, Verstovsek S, Mathews S, Andreeff M, Cortes JE. Phase I study of sorafenib in patients with refractory or relapsed acute leukemias. Haematologica. 2011 Jan;96(1):62-8. doi: 10.3324/haematol.2010.030452. Epub 2010 Oct 15.
PMID: 20952518DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge Cortes
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
October 1, 2005
Primary Completion
December 1, 2010
Last Updated
April 28, 2015
Record last verified: 2013-02