Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CYT387 · 1 trial · 3 indications
The Objective Response Rate (ORR), as measured by complete response (CR) rate, partial response (PR) rate and clinical improvement (CI) rate according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) is to be measured at the end of every cycle of therapy.
The pharmacokinetics (PK) of CYT387 in patients with PMF or post-ET/PV MF is to be assessed on Day 1 and Day 28 in Cycle 1 of therapy
| Arm | Type | Description |
|---|---|---|
| CYT387 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CYT387 | DRUG | For the Part 1 dose-escalation portion of the study, patients will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 100 mg/day. CYT387 will be orally self-administered as a single daily dose beginning on Day 1 of the study, and thereafter at approximately the same time each day of the 28-day cycle. It is recommended that all doses be preceded by a 2-hour fast from food and beverages, and be followed by a 1-hour post-dose fast from food and beverages. Twenty additional patients will be assigned to a 150 mg BID (twice daily) dosing schedule. CYT387 will be orally self-administered twice-daily with doses approximately 10-12 hours apart beginning on Day 1 of the study, and thereafter at approximately the same times each day of the 28-day cycle. For the Part 2 dose confirmation portion of the study, patients will be assigned to either 150 mg or 300 mg QD (once daily) dose groups. |
Inclusion Criteria: * Diagnosis of PMF or post-polycythemia Vera (PV) or post-essential Thrombocythemia (ET) MF as per revised World Health Organization (WHO) criteria. * High-risk or Intermediate-2 risk MF (as defined by the International Prognostic Scoring System \[IPSS\]; Appendix 13.6); or inte...
CYT387 is an investigational small molecule being studied for the treatment of Primary Myelofibrosis, as well as Post-Polycythemia Vera Myelofibrosis and Post-Essential Thrombocythemia Myelofibrosis. It is a targeted therapy designed to address the underlying disease process in these myeloproliferative conditions.
CYT387 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with myelofibrosis.
CYT387 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients with Primary Myelofibrosis and related conditions.
CYT387 has been studied in one completed clinical trial, registered as NCT00935987. This Phase 1 study evaluated the safety and efficacy of CYT387 in patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis, enrolling 166 participants across the United States, Australia, and Canada.
Yes, CYT387 is also known as momelotinib. This alternative name is used in scientific literature and clinical trial registries to refer to the same investigational drug being developed by GSK plc for the treatment of myelofibrosis.