Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01392443
Phase
PHASE2
Status
Completed

Conditions

  • Post-Essential Thrombocythemia (ET) MF
  • Post-Polycythemia Vera (PV) MF
  • Primary Myelofibrosis (MF)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength was 5 mg/tablet INC424 phosphate (free base equivalent).

Study Details

The objective of this study was to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume was also assessed.

Key Dates

Start date
Oct 14, 2010
Status verified
Aug 2019
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
120 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    Ruxolitinib was taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count \>200,000/μL (approximately 12 hours apart: morning and night), increased or decreased per standardized dosing paradigm.

Primary Outcome Measure

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24 [ Time Frame: 24 weeks ]

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