- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00217646
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
Study Overview
Status
Conditions
- Previously Treated Myelodysplastic Syndrome
- Recurrent Adult Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Secondary Myelodysplastic Syndrome
- de Novo Myelodysplastic Syndrome
- Adult Acute Monoblastic Leukemia
- Adult Acute Monocytic Leukemia
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With Maturation
- Adult Acute Myeloid Leukemia With Minimal Differentiation
- Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia Without Maturation
- Adult Acute Myelomonocytic Leukemia
- Alkylating Agent-Related Acute Myeloid Leukemia
- Adult Acute Megakaryoblastic Leukemia
- Adult Erythroleukemia
- Adult Pure Erythroid Leukemia
- Adult Acute Basophilic Leukemia
- Adult Acute Eosinophilic Leukemia
- Blastic Phase
- Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
- Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- No other concurrent anticancer agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent therapeutic anticoagulation (Concurrent prophylactic anticoagulation [i.e., low-dose warfarin, catheter flushing with heparin] of venous or arterial access devices allowed)
- No concurrent cytochrome P450 enzyme-inducing antiepileptic agents, including, but not limited to, any of the following: Phenytoin; Carbamazepine; Phenobarbital; Rifampin
- No concurrent Hypericum perforatum (St. John's wort)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm I
Patients receive oral sorafenib once or twice daily on days 1-5, 8-12, and 15-19.
|
Given orally
Other Names:
|
EXPERIMENTAL: Arm II
Patients receive oral sorafenib once or twice daily on days 1-14.
|
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum tolerated dose (MTD) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Precancerous Conditions
- Leukocyte Disorders
- Leukemia, Lymphoid
- Eosinophilia
- Cell Transformation, Neoplastic
- Carcinogenesis
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neoplasm Metastasis
- Recurrence
- Preleukemia
- Leukemia, Myelomonocytic, Acute
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Monocytic, Acute
- Leukemia, Megakaryoblastic, Acute
- Leukemia, Erythroblastic, Acute
- Hypereosinophilic Syndrome
- Blast Crisis
- Leukemia, Promyelocytic, Acute
- Leukemia, Basophilic, Acute
- Leukemia, Eosinophilic, Acute
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- NCI-2009-00081 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (U.S. NIH Grant/Contract)
- U01CA062461 (U.S. NIH Grant/Contract)
- 6742 (OTHER: CTEP)
- CDR0000442847
- 2004-0702 (OTHER: M D Anderson Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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