INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. (JUMP)
|ClinicalTrials.gov Identifier: NCT01493414|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelofibrosis||Drug: INC424||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2232 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).|
|Actual Study Start Date :||August 16, 2011|
|Actual Primary Completion Date :||January 26, 2016|
|Actual Study Completion Date :||January 26, 2016|
5 - 25 mg twice a day, per os
All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 25 mg twice a day. No INC424 dose will exceed 25 mg BID orally.
Other Name: Ruxolitinib
- Number of participants with treatment related adverse events up to 5 years [ Time Frame: Baseline up to approximately 5 years. ]The occurrence of adverse events may be volunteered by the patient or obtained by non-directive questioning at each visit during the study or through physical examination, laboratory test, or other assessments.
- Best overall response up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using IWG MRT criteria. Spleen response is also analyzed by proportion of patients achieving at least 50% reduction in spleen length at any time during the study.
- Change in ECOG Performance Status up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]ECOG performance score will be summarized from baseline versus worst-post baseline scores.
- Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) total scores up to Week 48. [ Time Frame: Baseline to Week 48. ]The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale) which in turn contribute to three total sum scores, namely FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) total score and FACT- Lym total score.
- Medical resource utilization up to 5 years. [ Time Frame: Baseline up to approximately 5 years. ]Percentage of patients requiring medical ressources (blood tranfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) by quarter and up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493414
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|