Trials / Terminated
TerminatedNCT00387426
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
Detailed description
PRIMARY OBJECTIVE: I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate. SECONDARY OBJECTIVE: 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sunitinib malate | Given PO |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2006-10-13
- Last updated
- 2014-05-28
- Results posted
- 2012-08-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00387426. Inclusion in this directory is not an endorsement.