Clinical Trials Logo
  1. Home
  2. Primary Myelofibrosis
  3. NCT01236638

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)

Primary Myelofibrosis Clinical Trial

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

Clinical Trial Summary

This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 (momelotinib) will be evaluated.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01236638
Study type Interventional
Source Sierra Oncology, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date June 2014
View Details
See also
  Status Clinical Trial Phase
Completed NCT01178281 - Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Phase 3
Not yet recruiting NCT06327100 - Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF) Phase 2
Active, not recruiting NCT00095784 - Decitabine in Treating Patients With Myelofibrosis Phase 2
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Terminated NCT02091752 - A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial) Phase 2
Completed NCT01445769 - Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Unknown status NCT01298934 - LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase 1/Phase 2
Terminated NCT00387426 - Sunitinib in Treating Patients With Idiopathic Myelofibrosis Phase 2
Completed NCT05044026 - A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
Active, not recruiting NCT03952039 - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib Phase 3
Active, not recruiting NCT02530619 - Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia N/A
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT01731951 - Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis Phase 2
Not yet recruiting NCT06468033 - P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk Phase 3
Completed NCT01371617 - A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase 2
Active, not recruiting NCT02251821 - JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis Phase 2
Active, not recruiting NCT04446650 - A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) Phase 1/Phase 2
Completed NCT01981850 - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Phase 2
Withdrawn NCT04283526 - Study of Select Combinations in Adults With Myelofibrosis Phase 1