Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01433445
Phase
PHASE1
Status
Completed

Conditions

  • Idiopathic Myelofibrosis
  • Post Essential Thrombocythemia Myelofibrosis
  • Post Polycythemia-Vera Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • panobinostat — DRUG
    Given 3 times a week, every other week in 28-day cycles.
  • ruxolitinib — DRUG
    Given twice daily in 28-day cycles.

Study Details

This study will assess safety as well as establish a Recommended Phase II dose of the combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).

Key Dates

Start date
Nov 1, 2011
Status verified
Jun 2021
Primary completion
Jun 22, 2020
Completion
Jun 22, 2020

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Subjects will be treated with ruxolitinib 5 mg twice daily (BID) and panobinostat 10 mg three times per week (TIW) every other week (QOW) on a 28 day cycle
  • Experimental: Cohort 2
    Subjects will be treated with ruxolitinib 10 mg twice daily (BID) and panobinostat 10 mg three times per week (TIW) every other week (QOW) on a 28 day cycle
  • Experimental: Cohort 3
    Subjects will be treated with ruxolitinib 15 mg twice daily (BID) and panobinostat 10 mg three times per week (TIW) every other week (QOW) on a 28 day cycle
  • Experimental: Cohort 4
    Subjects will be treated with ruxolitinib 15 mg twice daily (BID) and panobinostat 15 mg three times per week (TIW) every other week (QOW) on a 28 day cycle
  • Experimental: Cohort 5
    Subjects will be treated with ruxolitinib 15 mg twice daily (BID) and panobinostat 20 mg three times per week (TIW) every other week (QOW) on a 28 day cycle
  • Experimental: Cohort 6/6+
    Subjects will be treated with ruxolitinib 15 mg twice daily (BID) and panobinostat 25 mg three times per week (TIW) every other week (QOW) on a 28 day cycle

Primary Outcome Measure

Rate of dose limiting toxicities at the different dose levels [ Time Frame: Cycle 1 (a cycle = 28 days) ]

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