Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelofibrosis; Polycythemia Vera; Thrombocytosis
Intervention: Ruxolitinib (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Incyte Corporation Official(s) and/or principal investigator(s): Srdan Verstovsek, MD, PhD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center, Houston, TX Ayalew Tefferi, MD, Principal Investigator, Affiliation: Mayo Clinic, Rochester, MN
Summary
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).
Clinical Details
Official title: 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)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants With Adverse Events (AEs)Percentage of Participants With Clinical Improvement (CI) Over Time
Secondary outcome: Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over TimePercentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 Change From Baseline to Week 24 in Health-Related Quality of Life Change From Baseline in Body Weight Over Time Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status
Detailed description:
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Rochester, Minnesota, United States
Houston, Texas, United States
Additional Information
Starting date: June 2007
Last updated: July 30, 2015
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