Phase 2
N=14
Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis
Anemia · Primary Myelofibrosis · Secondary Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01732445 ↗Enrolled (actual)
14
Serious AEs
50.0%
Results posted
Oct 2017
Primary outcome: Primary: Best Overall Response Rate as Determined by International Working Group Criteria — 28.6 percentage of patients with CR, PR or CI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ruxolitinib phosphate (Drug); danazol (Drug); quality-of-life assessment (Other); questionnaire administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate as Determined by International Working Group Criteria |
28.6 | — |
| SECONDARY Survival Time |
19.2 | — |
| SECONDARY Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) |
7.1; 64.3; 7.1; 14.3; 7.1; 7.1 | — |
Summary
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.
Eligibility Criteria
Inclusion Criteria
- Histological confirmation of primary myelofibrosis (MF), post polycythemia vera (PV) or post essential thrombocythemia (ET) myelofibrosis (intermediate 1, intermediate II or high risk) requiring medical therapy
- Anemia is required for trial entry (defined as hemoglobin = 1000/uL
- Platelet count >= 50,000/uL
- Serum creatinine = 1.5 x ULN, a direct bilirubin should be performed and must be = 6 months
- Patient able to provide voluntary written informed consent to participate
- Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures
- Negative pregnancy test done = 10 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin), hormones (e.g., androgens, danazol) = 4 ng/ml or with uncontrolled benign prostatic hypertrophy
- Patient received prior combination treatment with ruxolitinib and danazol together; note: previous treatment with ruxolitinib and/or danazol as single agent therapy is allowed
- Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration
- Strong inhibitors of CYP3A4:
- Indinavir (Crixivan)
- Nelfinavir (Viracept)
- Atazanavir (Reyataz)
- Clarithromycin (Biaxin, Biaxin XL)
- Itraconazole (Sporanox)
- Ketoconazole (Nizoral)
- Nefazodone (Serzone)
- Saquinavir (Fortovase, Invirase)
- Telithromycin (Ketek)
- Moderate inhibitors of CYP3A4
- Erythromycin (Erythrocin, E.E.S., Ery-Tab, Eryc, EryPed, PCE)
- Fluconazole (Diflucan)
- Grapefruit juice
- Verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan)
- Verelan PM
- Diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
Data sourced from ClinicalTrials.gov (NCT01732445). 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.