Phase 2
N=77
CC-4047 in Treating Patients With Myelofibrosis
Chronic Myeloproliferative Disorders · Secondary Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00669578 ↗Enrolled (actual)
77
Serious AEs
29.2%
Results posted
May 2014
Primary outcome: Primary: Determine the Maximum Tolerated Dose of CC-4047 — 0; 0; 66 percentage of participants with DLT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CC-4047 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Maximum Tolerated Dose of CC-4047 |
0; 0; 66 | — |
| PRIMARY Best Overall Response Over the First 6 Cycles of Treatment |
0; 0; 9 | — |
| SECONDARY Number of Participants With Treatment Related Adverse Events. |
6; 3; 0 | — |
| SECONDARY Duration of Response Time |
5.6 | — |
| SECONDARY Time to Response |
— | — |
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of primary and post essential thrombocythemia (ET) or post polycythemia vera (PV) myelofibrosis requiring therapy
- De novo presentation (i.e., agnogenic myeloid metaplasia AND post ET or post PV myelofibrosis)
- Developed after an antecedent history of PV (i.e., post polycythemic myeloid metaplasia) or essential polycythemia (i.e., post thrombocythemic myeloid metaplasia)
- Total hemoglobin 2 weeks) of more than physiologic doses of corticosteroids (dose equivalent to > 10 mg/day of prednisone)
Data sourced from ClinicalTrials.gov (NCT00669578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.