Clinical Trial: Sunitinib in Treating Patients With Idiopathic Myelofibrosis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 12, 2006
Date Started: September 2006
Date Completion:
Last Updated: May 12, 2014
Last Verified: October 2013