Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|ClinicalTrials.gov Identifier: NCT00387426|
Recruitment Status : Terminated
First Posted : October 13, 2006
Results First Posted : August 14, 2012
Last Update Posted : May 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Accelerated Phase Chronic Myelogenous Leukemia Acute Undifferentiated Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blastic Phase Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia Chronic Phase Chronic Myelogenous Leukemia Mast Cell Leukemia Meningeal Chronic Myelogenous Leukemia Primary Myelofibrosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia T-cell Large Granular Lymphocyte Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Adult Acute Myeloid Leukemia Untreated Hairy Cell Leukemia||Drug: sunitinib malate||Phase 2|
I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate.
I. Assess the safety of sunitinib malate in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral sunitinib malate once daily for 6 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis|
|Study Start Date :||September 2006|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
Experimental: Arm I
Patients receive oral sunitinib malate once daily for 6 weeks.
Drug: sunitinib malate
- Number of Participants With Objective Clinical Response to Sunitinib Therapy [ Time Frame: After two 6-week treatment courses (12 weeks) ]Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387426
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Srdan Verstovsek||M.D. Anderson Cancer Center|