Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)
|ClinicalTrials.gov Identifier: NCT01236638|
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : July 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Primary Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis||Drug: Momelotinib||Phase 2|
The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN share a range of biological, pathological, and clinical features including the relative overproduction of one or more cells of myeloid origin, growth factor independent colony formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005).
This is a multi centre, open-label, extension study of the core study (CCL09101). The primary aims of the study will be to determine the long term safety and tolerability of orally-administered CYT387 when administered as a capsule dose, on a 28-day treatment cycle.
Following completion of the core study (CCL09101), patients who have tolerated the drug and derived clinical benefit will continue to be treated with CYT387 administered orally.
Subjects will be evaluated every three months for up to 24 cycles of CYT387 treatment. Subjects will return for a follow-up visit 30 days after completion of the last dose of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label Extension Study Evaluating the Long Term Safety, Tolerability & Efficacy of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Patients will continue receiving the same doses as assigned during the CCL09101 protocol; up to 400 mg once per day (QD). CYT387 will be administered orally as a single daily dose (at least 20 and no more than 28 hours apart, preferably in a fasted state at least two hours before and one hour after a meal), except for patients on the twice daily (BID) dosing regime (150 mg BID).
Other Name: CYT387
- To determine the long term safety and tolerability of orally-administered CYT387 in patients with PMF or post-ET/PV MF following completion of core study CCL09101 [ Time Frame: Safety monitoring will be undertaken for all patients every 3 months ]
- To obtain information on the long term effectiveness of orally-administered CYT387 in patients with PMF or post-ET/PV MF [ Time Frame: Every three months ]Measured by complete response (CR) rate, partial response (PR) rate and clinical improvement (CI) rate according to IWG-MRT consensus criteria
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236638
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94305-5821|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|The Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Study Chair:||Ayalew Tefferi, MD||Mayo Clinic|