Sorafenib Plus 5-Azacitidine Initial Therapy of Patients With Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MS) With FLT3-ITD Mutation
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|ClinicalTrials.gov Identifier: NCT02196857|
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Azacytidine Drug: Sorafenib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sorafenib Plus 5-Azacitidine for the Initial Therapy of Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome With FLT3-ITD Mutation|
|Actual Study Start Date :||February 6, 2015|
|Actual Primary Completion Date :||November 27, 2018|
|Actual Study Completion Date :||November 27, 2018|
Experimental: Azacytidine + Sorafenib
Azacitidine 75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) daily for 7 days per 28 day cycle. Sorafenib administered orally at a dose of 400 mg twice daily every day continuously.
75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.
400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle.
- Overall Response of Azacytidine and Sorafenib [ Time Frame: After 3, 28 day cycles ]Criteria for response per the International Working Group for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Data analysis performed using SAS or S-plus, as appropriate. All patients who received at least 1 dose of the combined agents will be included in the intent-to-treat analysis for efficacy. . Overall response rates presented with 95% confidence intervals. Association between response and patient and disease characteristics examined by two-sample t-test or Chi-square test.
- Toxicity Profile of Azacytidine and Sorafenib [ Time Frame: After 3, 28 day cycles ]Severity of toxicities graded according to the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency. Proportion of patients with adverse events (AEs) estimated, along with the Bayesian 95% credible interval. Descriptive summaries provided for all patients for each safety parameter by cycle, grade, and relationship to treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196857
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|