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CINC424A2X01B Rollover Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02386800
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This roll-over protocol allows patients who are still receiving clinical benefit to continue to be treated from multiple protocols in one program spanning multiple indications during the completion of the parent study/(ies). The population for the roll-over study should be consistent with the population defined in the program parent study/(ies). The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis GDD&GMA/Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters would not be measured; however safety data and an evaluation of clinical benefit will be collected.

Patients who have completed a prior study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat and who are assessed by the Investigator to continue to benefit from ongoing treatment will be eligible.

Condition or disease Intervention/treatment Phase
Splenomegaly Drug: Ruxolitinib Drug: Panobinostat Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multi-center, Phase IV Rollover Protocol for Patients Who Have Completed a Global Novartis or Incyte Sponsored Ruxolitinib (INC424) or Ruxolitinib and Panobinostat (LBH589) Combination Study and Are Judged by the Investigator to Benefit From Continued Treatment
Actual Study Start Date : March 5, 2015
Estimated Primary Completion Date : September 17, 2025
Estimated Study Completion Date : September 17, 2025

Arm Intervention/treatment
Experimental: Ruxolitinib Drug: Ruxolitinib

Experimental: Panobinostat, Ruxolitinib Drug: Panobinostat

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: through study completion estimated to be approximately 10 years ]
    Adverse Events will be monitored throughout the trial.

Secondary Outcome Measures :
  1. To evaluate clinical benefit as assessed by the investigator [ Time Frame: through study completion estimated to be approximately 10 years ]
    Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, is receiving either ruxolitinib or combination of ruxolitinib and panobinostat and fulfilled all of the requirements of the parent protocol.
  2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
  3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
  4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
  5. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
  6. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.
  2. Patient's indication is currently approved and reimbursed in the local country
  3. Patient has participated in a combination trial (other than the specified panobinostat and ruxolitinib combination trial) where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy.
  4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG lab test.
  5. Women of child-bearing potential, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up.
  6. Female patients between ≥ 12 and < 18 years of age and of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception as defined below, throughout the study and for up to 30 days after stopping treatment.

Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02386800

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Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals +81337978748

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT02386800     History of Changes
Other Study ID Numbers: CINC424A2X01B
2014-003527-22 ( EudraCT Number )
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
primary myelofibrosis
chronic idiopathic myelofibrosis,
post polycythemia vera myelofibrosis,
post essential thrombocythaemia myelofibrosis,
Steroid Refractory Graft Versus Host Disease
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action