Active — Not RecruitingPhase 4

CINC424A2X01B Rollover Protocol

Australia279 participantsStarted 2015-03-05

Plain-language 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.

Who can participate

Age range1 Month – 100 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Incidence and severity of AEs and SAEs

Timeframe: 12 years

Trial details

NCT IDNCT02386800

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-16

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