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Clinical Trial 20634

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04173494

Phase: Phase III
Principal Investigator: Kuykendall, Andrew

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Overview

Study Title

A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV)Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

Summary

Objective

To determine the efficacy of MMB versus DAN assessed by improvement in Myelofibrosis Symptom Assessment Form v4.0 (MFSAF) total symptom score (TSS) in subjects with PMF, post-PV myelofibrosis (MF), or post-ET MF who were previously treated with approved JAK inhibitor therapy

Treatments

Therapies

Therapy (NOS)

Medications

Danazol (); Momelotinib (); Momelotinib/Danazol/Placebo ()

Inclusion Criteria

18 years of age or older

Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT criteria).

Symptomatic, defined as a TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Day BL1.

Anemic, as defined in protocol.

Previously treated with an approved JAK inhibitor for PMF or Post-PV/ET MF for ≥ 90 days, or ≥ 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of ≥ 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma.

Baseline splenomegaly, defined as having a palpable spleen at ≥ 5 cm, below the left costal margin, or with volume ≥ 450 cm³ on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization.

High risk, intermediate-2, or intermediate-1 risk MF as defined by DIPSS, or DIPSS-plus.

No allogeneic stem cell transplant planned.

Acceptable laboratory assessments as defined per protocol

ECOG performance status of 0, 1 or 2

Women of Child Bearing Potential (WOCBP) men with partners of childbearing potential, and patients with pregnant or lactating partners must agree to follow the contraceptive requirements of the protocol, effective for the first administration of MMB, throughout the trial and for 6 months after the last dose of MMB.

Additional Criteria may apply

Exclusion Criteria

Exclusion Criteria:

Use of the following treatments within the time periods noted: (a) MMB treatment at any time. (b) Approved JAK inhibitor therapy (e.g. fedratinib or ruxoliitinib) within 1 week prior to Day BL1. (c) Active anti-MF therapy as defined in protocol. within 1 week prior to Day BL1. Supportive care including steroids for non-MF indications may be used as defined in protocol. (d) Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to Randomization. (e) Investigational agent (including investigational JAK inhibitors) within 4 weeks prior to Randomization. (f) Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization. (g) Danazol within 3 months prior to Randomization. (h) Splenic irradiation within 3 months prior to Randomization. (i) Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.

History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured.

Prostate specific antigen (PSA) > 4 ng/mL.

Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI or CT scan for spleen volume measurement per protocol requirements.

Any of the following Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial). Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization. Unstable angina pectoris within 6 months prior to Randomization.Symptomatic congestive heart failure within 6 months prior to Randomization.Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.QTcF interval > 500 msec, unless attributed to bundle branch block. Current progressive thrombosis despite treatment. History of porphyria. Child-Pugh score ≥ 10. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment.

Patients with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efﬁcacy assessment of the investigational regimen.

Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia

Known positive status for HIV.

Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C).

Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per CTCAE v5.0.

Presence of peripheral neuropathy ≥ Grade 2 per CTCAE v5.0.

Women who are already pregnant or lactating.

Additional inclusion/exclusion criteria may apply.

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