Trial intelligence / Profile preview

Momelotinib in Polycythemia Vera or Essential Thrombocythemia

NCT01998828Phase 2

Key facts

Status: Terminated
Start: Feb 2014
Primary completion: Mar 2015
Countries: 5
Sponsor: GSK
Modality: Small Molecules

Drugs: momelotinib dihydrochloride
Conditions: polycythemia vera (PV)essential thrombocythemia (ET)

Overview

Phase 2, randomised, open-label trial of momelotinib dihydrochloride in polycythemia vera (PV) and essential thrombocythemia (ET) (4 arms), sponsored by GSK. Primary endpoint: Overall Response Rate at 24 weeks. Started Feb 2014; status: terminated.

Design

4 arms

Study design: RandomizedOpen-label

Momelotinib 100 mg PV
Participants with polycythemia vera receive 100 mg of momelotinib.
Momelotinib 200 mg PV
Participants with polycythemia vera receive 200 mg of momelotinib.
Momelotinib 100 mg ET
Participants with essential thrombocythemia receive 100 mg of momelotinib.
Momelotinib 200 mg ET
Participants with essential thrombocythemia receive 200 mg of momelotinib.

Who it enrols

Patients with PV or ET who are JAK inhibitor-naive, have not had a prior splenectomy, and have adequate organ function.

Endpoints

Primary

Overall Response Rate24 weeks

Secondary

Confirmed Overall Response Rate24 weeks
Hematocrit < 45%24 weeks
WBC < 10 x 10^9/L24 weeks
Platelet count <= 400 x 10^9/L24 weeks
Resolution of Palpable Splenomegaly24 weeks
MPNSAF TSS Improvement24 weeks

Results

Not all primary endpoints met

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