Status:
COMPLETED
Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Idiopathic Myelofibrosis
Post Essential Thrombocythemia Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will assess safety as well as establish a Recommended Phase II dose of the combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F mutation who have been diagn...
Detailed Description
In 2011 the treatment goals for MF focused on symptom-orientated palliation and quality of life. Both ruxolitinib and panobinostat, as single agents, had shown significant improvement in both of those...
Eligibility Criteria
Inclusion
- Diagnosis of myelofibrosis, either PMF, PPV or PET MF
- Palpable splenomegaly ≥ 5cm
- May have been previously treated with either panobinostat or ruxolitinib (unless discontinued for clinically relevant toxicities)
- Acceptable lab ranges for all organ systems
- Specifically: Platelet count \> 100,000 not reached with the aide of transfusions
- Blast count \< 10% at screening
- ECOG ≤ 2
- Must be able to discontinue all drugs being used to treat MF at least 7 days prior to starting study drug
Exclusion
- Active malignancy
- Clinically significant heart disease
- Splenic irradiation within 12 months of starting study drug
- Need for ongoing systemic anticoagulation with the exception of Aspirin \< 150mg/day or Low Molecular Weight Heparin
- History of platelet dysfunction or bleeding disorder in the 6 months prior to screening
- Patient is at risk for spontaneous bleeding
- Willing and/or eligible for stem-cell transplantation
- Impairment of gastro-intestinal function that may impact the absorption of study treatment
- Unwilling to use highly effective methods of contraception during dosing and for 13 weeks (female participants) or for 6 months (male participants and their female partners) after stopping study treatment
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2020
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01433445
Start Date
November 1 2011
End Date
June 22 2020
Last Update
June 25 2021
Active Locations (10)
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1
Novartis Investigative Site
Paris, France, 75010
2
Novartis Investigative Site
Villejuif, France, 94800
3
Novartis Investigative Site
Magdeburg, Germany, 39120
4
Novartis Investigative Site
Mainz, Germany, 55131