This roll-over study is designed to accept patients with varied disease origins. Please refer to the parent protocol for the disease background information and rationale for use of ruxolitinib in their individual indications.
Conditions
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is currently enrolled in a Novartis OGD 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 ruxolitinib and has fulfilled all of the requirements of the parent protocol. - Patient is currently benefiting from the treatment with ruxolitinib, as determined by the investigator - Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements - Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures - Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
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 - Patient has participated in a combination trial where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy. - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up. Highly effective contraception methods include: see protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To allow continued treatment to patients receiving ruxolitinib in existing global Novartis or Incytesponsored studies who are benefiting from treatment after conclusion of the parent study.;Secondary Objective: To collect long term data on adverse events (AEs) and serious adverse events (SAEs).;Primary end point(s): - Number of patients receiving ruxolitinib.;Timepoint(s) of evaluation of this end point: No statistical analysis will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency and nature of adverse events and serious adverse events.;Timepoint(s) of evaluation of this end point: The assessment of safety will be based on the frequency of adverse events (AEs) and serious adverse events (SAEs). | — |
Countries
Australia, Belgium, Germany, Greece, Hungary, Italy, Lebanon, Spain, Thailand, Turkey, United Kingdom
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed