Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Hematology, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2007 |
| End Date: | February 2017 |
A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424),
administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera
Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).
administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera
Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).
This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a
small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF,
PPEV-MF or PET-MF. The study is comprised of 3 parts:
Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (complete).
Part 3: Further evaluation of selected dose regimens, including additional response measures
to explore effect of ruxolitinib on symptoms and other parameters including daily physical
activity and long-term survival (ongoing).
small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF,
PPEV-MF or PET-MF. The study is comprised of 3 parts:
Part 1: Dose escalation and determination of maximum tolerated dose (complete).
Part 2: Exploration of alternative dosing schedules (complete).
Part 3: Further evaluation of selected dose regimens, including additional response measures
to explore effect of ruxolitinib on symptoms and other parameters including daily physical
activity and long-term survival (ongoing).
Inclusion Criteria:
- Diagnosed with PMF or Post-PV/ET MF
- Patients with myelofibrosis requiring therapy
- Adequate bone marrow reserve
Exclusion Criteria:
- Received anti-cancer medications or investigational therapy in the past 14 days
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials