NCT00669578

CC-4047 in Treating Patients With Myelofibrosis

A Phase I/II, Prospective, Open-Label Study to Determine the Safety and Efficacy of CC-4047 in Patients With Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis®

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer cells by blocking blood flow to the cancer. PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well it works in treating patients with myelofibrosis.

Detailed description

OBJECTIVES: Phase I: Primary * To determine the Maximum Tolerated Dose of CC-4047 in the treatment of Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF). Phase II: Primary * Best overall response as determined by International Working Group Criteria over the first 6 cycles (168 days) of study treatment. Secondary * Safety (type, frequency, severity \[National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0\] of adverse events (AEs), and relationship of AEs to CC-4047. * Duration of response. * Time to response. * Best overall response as determined by International Working Group Criteria over the first 12 cycles (336 days) of study treatment. OUTLINE: Patients receive oral CC-4047. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28 days and then every 6 months for up to 3 years.

Conditions

• Chronic Myeloproliferative Disorders
• Secondary Myelofibrosis

Interventions

Type	Name	Description
DRUG	CC-4047	CC-4047: taken orally each day in a 28 day cycle.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-07-07
• Completion: 2019-12-12
• First posted: 2008-04-30
• Last updated: 2019-12-30
• Results posted: 2014-05-09

Locations

1 site across 1 country: United States