CINC424A2X01B Rollover Protocol

Summary

Participation Requirements

Description

Protocol number: CINC424A2X01B Full title An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study, and are judged by the investigator to b...

Protocol number: CINC424A2X01B Full title An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study, and are judged by the investigator to benefit from continued treatment. Brief title An open label, multi-center, Phase IV rollover protocol to evaluate long term safety data Sponsor and Clinical Phase: Novartis, IV Investigation type Drug Study type Interventional Purpose and rationale The purpose of this study is to evaluate long term safety data and to allow patients continued use of ruxolitinib monotherapy or combination of ruxolitinib and panobinostat who have been receiving treatment in a Novartis-sponsored Global Drug Development (GDD) or Global Medical Affairs (GMA) study or Incyte-sponsored study that has reached its study objectives, are not progressing on the current study treatment as defined by the parent protocol, have completed their obligations, and are unable to access ruxolitinib or combination of ruxolitinib and panobinostat outside of a clinical trial. Patients must be benefiting from treatment as judged by the investigator at the completion of the parent study. Primary Objective(s) To evaluate long term safety data i.e. SAEs and AEs Secondary Objectives To evaluate clinical benefit as assessed by the investigator. Study design This is a multi-center, open label study to evaluate long term safety of ruxolitinib monotherapy or combination of ruxolitinib and panobinostat in patients from a Novartis-sponsored Global Drug Development (GDD) or Global Medical Affairs (GMA) study or Incyte-sponsored study that has reached its study objectives, or who are not progressing on the current study treatment or who are on parent study and have completed their obligations and are unable to access ruxolitinib or combination of ruxolitinib and panobinostat, outside of a clinical study, and are benefiting from treatment as judged by the investigator at the completion of the parent study. Population Male and female patients who are currently enrolled in a Novartis-sponsored Global Drug Development (GDD) or Global Medical Affairs (GMA) study or Incyte-sponsored study that has reached its study objectives, or who are not progressing on the current study treatment as defined by the parent protocol, or who are on parent study and have completed their obligations and are unable to access ruxolitinib or combination of ruxolitinib and panobinostat outside of a clinical study. Patients must be benefiting from treatment as judged by the investigator at the completion of the parent study. This rollover study allows patients from parent studies with indications including but not limited to myelofibrosis (MF), polycythemia vera (PV), acute GvHD (aGvVHD) or chronic GvHD (cGvHD). The study must be in the process of being completed & reported. For Pediatric GvHD Population*: • Male and females ages ≥28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD or with either moderate to severe treatment-naive cGvHD or SR-cGvHD *Pediatric GvHD population herein refers to both pediatric and adolescents from parent protocols: CINC424F12201 (REACH-4) and CINC424G12201 (REACH-5). Key Inclusion criteria Patient is currently enrolled in a Novartis-sponsored Global Drug Development (GDD) or Global Medical Affairs (GMA) study or Incyte-sponsored study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, and 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. Key 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 local country for ruxolitinib monotherapy or other study drugs in the combination treatment (panobinostat). Investigational and reference therapy INC424 / ruxolitinib / Jakavi / Jakafi (United States [US] brand) LBH589 / panobinostat / Farydak Efficacy assessments At every quarterly visit, the investigator is required to confirm that the patient continues to have clinical benefit and may continue receiving ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Safety assessments Frequency and nature of adverse events and serious adverse events GvHD Patient Population: At every quarterly visit, the investigator is required to confirm any infections or, second primary malignancies under Adverse Events. Pediatric GvHD population*: At every yearly visit, the investigator is to determine the Tanner staging (if applicable). *Pediatric GvHD population herein refers to both pediatric and adolescents from parent protocols: CINC424F12201 (REACH-4) and CINC424G12201 (REACH-5). Adolescent and Pediatric GvHD Patients: height and weight monitoring is required yearly by the investigator until 18 years old. Other assessments Not applicable Data analysis The statistical analysis will be descriptive only, summarizing safety data and clinical benefit as assessed by the investigator, for the overall population and by indication. The incidence of treatment emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on CTCAE grades), and relation to study treatment. For pediatric GvHD patients ≤18 years of age, height and Body Mass Index (BMI) will be summarized at yearly intervals, using descriptive statistics. All height/BMI data will be listed. ingThe statistical analysis will mainly focus on be imited to report frequency and severity of AEs and SAEs as outlined in Section 10. Key words JAK inhibitor, Rollover Protocol

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