CINC424A2X01B Rollover Protocol
Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies
Novartis Pharmaceuticals
296 participants
Mar 5, 2015
INTERVENTIONAL
Conditions
Summary
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
Eligibility
Inclusion Criteria4
- Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
- Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
- Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
- Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
Exclusion Criteria4
- Patient has been permanently discontinued from study treatment in the parent study due to any reason.
- Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
- Pregnant or nursing (lactating) women.
- Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
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Interventions
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Locations(101)
View Full Details on ClinicalTrials.gov
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NCT02386800