Chronic Myeloproliferative Disorders Clinical Trial
Official title:
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®
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.
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.
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