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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 Time

Percentage 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

Page last updated: August 23, 2015

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