Terminated PHASE2 INTERVENTIONAL 1-arm NCT00387426

Sunitinib in Treating Patients With Idiopathic Myelofibrosis

A Phase II Study of Sunitinib Malate in Idiopathic Myelofibrosis

Sponsor: National Cancer Institute (NCI)

Interventions sunitinib malate

Updated 7 times since 2017 Last updated: May 12, 2014 Started: Sep 30, 2006 Primary completion: Feb 28, 2009 Completion: Feb 28, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

This PHASE2 trial investigates Accelerated Phase Chronic Myelogenous Leukemia and Acute Undifferentiated Leukemia and is currently terminated or withdrawn. National Cancer Institute (NCI) leads this study, which shows 7 recorded versions since 2006 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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.

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.

Status Flow

Change History

7 versions recorded

Jan 2026 — Present [monthly]

Terminated PHASE2
Sep 2024 — Present [monthly]

Terminated PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE2
Jan 2021 — Jul 2024 [monthly]

Terminated PHASE2
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Terminated PHASE2
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE2

First recorded

Sep 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Houston, United States