CINC424A2X01B Rollover Protocol
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|ClinicalTrials.gov Identifier: NCT02386800|
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : September 26, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||356 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Panobinostat, Ruxolitinib||
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02386800
|Contact: Novartis Pharmaceuticals||+41613241111|
|Contact: Novartis Pharmaceuticals||+81337978748|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|