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NCT01433445
Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis
Phase 1 trial testing panobinostat in Idiopathic Myelofibrosis in 61 participants. Completed in 22 June 2020.
22 June 2020
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 1 November 2011 |
| Primary completion | 22 June 2020 |
| Estimated completion | 22 June 2020 |
| Sites | 10 locations across France, Italy, Ireland, United Kingdom, Germany |
Drugs / interventions tested
- panobinostat (PANOBINOSTAT) — full drug profile →
- ruxolitinib (RUXOLITINIB) — full drug profile →
Conditions studied
- Idiopathic Myelofibrosis — all drugs for Idiopathic Myelofibrosis →
- Post Essential Thrombocythemia Myelofibrosis — all drugs for Post Essential Thrombocythemia Myelofibrosis →
- Post Polycythemia-Vera Myelofibrosis — all drugs for Post Polycythemia-Vera Myelofibrosis →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Idiopathic Myelofibrosis or Post Essential Thrombocythemia Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 diagnosed with primary myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Molecular pathways: molecular basis for sensitivity and resistance to JAK kinase inhibitors.
Meyer SC, Levine RL. · · 2014 · cited 139× · PMID 24583800 · DOI 10.1158/1078-0432.ccr-13-0279 -
Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.
Zhao A, Zhou H, Yang J, Li M, et al · · 2023 · cited 81× · PMID 36797244 · DOI 10.1038/s41392-023-01342-6 -
JAK2 inhibitors for myeloproliferative neoplasms: what is next?
Bose P, Verstovsek S. · · 2017 · cited 78× · PMID 28500170 · DOI 10.1182/blood-2017-04-742288 -
Clinical epigenetics settings for cancer and cardiovascular diseases: real-life applications of network medicine at the bedside.
Sarno F, Benincasa G, List M, Barabasi AL, et al · · 2021 · cited 49× · PMID 33785068 · DOI 10.1186/s13148-021-01047-z -
Ruxolitinib in combination with lenalidomide as therapy for patients with myelofibrosis.
Daver N, Cortes J, Newberry K, Jabbour E, et al · · 2015 · cited 47× · PMID 26088933 · DOI 10.3324/haematol.2015.126821 -
Beyond Ruxolitinib: Fedratinib and Other Emergent Treatment Options for Myelofibrosis.
Bewersdorf JP, Jaszczur SM, Afifi S, Zhao JC, et al · · 2019 · cited 28× · PMID 31920387 · DOI 10.2147/cmar.s212559 -
JAK2 mutants (e.g., JAK2V617F) and their importance as drug targets in myeloproliferative neoplasms.
Gäbler K, Behrmann I, Haan C. · · 2013 · cited 27× · PMID 24069563 · DOI 10.4161/jkst.25025 -
Challenges and Perspectives for Therapeutic Targeting of Myeloproliferative Neoplasms.
Brkic S, Meyer SC. · · 2021 · cited 26× · PMID 33403355 · DOI 10.1097/hs9.0000000000000516
Verify or expand the search:
- PubMed search for NCT01433445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of panobinostat
Trials testing the same drug.
- NCT02386800 — CINC424A2X01B Rollover Protocol · Phase 4 · active not recruiting
- NCT01658241 — Panobinostat Biological Correlates Study · Phase 2 · completed
- NCT01460940 — A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma · Phase 2 · completed
- NCT01261247 — Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma · Phase 2 · completed
Other recruiting trials for Idiopathic Myelofibrosis
Currently open trials in the same condition.
- NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01433445 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 25 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01433445.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing