Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT01254890|
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : May 6, 2016
Last Update Posted : May 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Azacitidine Drug: Sorafenib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Sorafenib and 5-Azacitidine for the Treatment of Patients With Refractory or Relapsed Acute Leukemia and Myelodysplastic Syndrome (MDS) - (VZ-MDS-PI-0227)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Azacitidine + Sorafenib
Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days; Sorafenib 200 mg orally twice a day.
75 mg/m^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle.
Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.
- Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine [ Time Frame: 28 day cycle ]MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine
- Phase II: Number of Participants With Response [ Time Frame: 90 days ]Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254890
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||UT MD Anderson Cancer Center|