Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
This study is currently recruiting participants.
Verified May 2013 by Incyte Corporation
Sponsor:
Incyte Corporation
Collaborator:
Novartis
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01317875
First received: March 14, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). Study will consist of 2 phases - dose escalation and safety expansion. Dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ninth power/L
| Condition | Intervention | Phase |
|---|---|---|
|
Myelofibrosis |
Drug: Ruxolitinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential thrombocythemia
polycythemia vera
primary myelofibrosis
U.S. FDA Resources
Further study details as provided by Incyte Corporation:
Primary Outcome Measures:
- To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling. [ Time Frame: Measured at the completion of each consecutive dose cohort using a Bayesian logistic regression model. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Characterize the safety of ruxolitinib by monitoring the frequency, duration and severity of adverse and serious adverse events. [ Time Frame: Baseline, weekly for the 1st month of the study and then every 2 weeks until study completion or early termination. In addition, safety will also be assessed through the spontaneous reporting of serious adverse events. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ruxolitinib |
Drug: Ruxolitinib
Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg BID Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Require treatment for MF and classified at least as intermediate risk level 1 defined by the International Working Group.
- Platelet count < 100x10 ninth power/L at screening or at Study Day 1.
Exclusion Criteria:
- Received platelet transfusion within 14 days prior to Screening evaluations.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317875
Contacts
| Contact: Incyte Corporation Call Center | 1.855.463.3463 |
Locations
| United States, Florida | |
| Recruiting | |
| Winter Park, Florida, United States, 32789 | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Texas | |
| Recruiting | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Incyte Corporation
Novartis
Investigators
| Study Director: | Lance Leopold, MD | Incyte Corporation |
More Information
No publications provided
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT01317875 History of Changes |
| Other Study ID Numbers: | CINC424A2201 |
| Study First Received: | March 14, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Thrombocythemia, Essential Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
Blood Coagulation Disorders Thrombocytosis Blood Platelet Disorders Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 21, 2013