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JOURNAL ONKOLOGIE – STUDIE

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Patients (MOMENTUM)

Rekrutierend

NCT-Nummer:
NCT04173494

Studienbeginn:
Februar 2020

Letztes Update:
06.04.2021

Wirkstoff:
Momelotinib, Danazol, Placebo to match momelotinib, Placebo to match danazol

Indikation (Clinical Trials):
Polycythemia Vera, Primary Myelofibrosis, Polycythemia, Thrombocytosis, Thrombocythemia, Essential

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Sierra Oncology, Inc.

Collaborator:
-

Studienleiter

Srdan Verstovsek, M.D., Ph.D.
Principal Investigator
Department of Leukemia, The University of Texas MD Anderson Cancer Center

Kontakt

Studienlocations
(3 von 167)

Kinderonkologisches Zentrum Universitätsklinikum Essen
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Ernst-Grube-Straße 40
06120 Halle (Saale)
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01307 Dresden
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Studien-Informationen

Brief Summary:

MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the

differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol

(DAN) in symptomatic and anemic subjects who have previously received an approved Janus

kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is

to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease

related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with

primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is

planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria,

Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand,

Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, UK, and US.

Subjects must be symptomatic with a MFSAF v4.0 Total Symptom Score of ≥ 10 at screening, and

be anemic with Hgb < 10 g/dL. For subjects with ongoing JAKi therapy at screening, JAKi

therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment

washout interval prior to randomization.

Subjects will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo

or DAN plus placebo. Subjects randomized to receive MMB who complete the randomized treatment

period to the end of Week 24 may continue to receive MMB in the open-label extended treatment

period to the end of Week 204 (a total period of treatment of approximately 4 years) if the

subject tolerates and continues to benefit from MMB.

Subjects randomized to receive DAN may cross-over to MMB open-label treatment in the

following circumstances:

- at the end of Week 24 if they complete the randomized treatment period; or

- at the end of Week 24 if they discontinue treatment with DAN but continue study

assessments and do not receive prohibited medications including alternative active

anti-MF therapy; or

- at any time during the randomized treatment period if they meet the protocol-defined

criteria for radiographically-confirmed symptomatic splenic progression.

Subjects randomized to receive DAN who are receiving clinical benefit at the end of Week 24

may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an

approved medication in the US and in some other countries and is recommended by national

guidelines as a treatment for anemia in MF.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age ≥ 18 years.

2. 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).

3. Symptomatic, defined as a TSS of ≥ 10 units assessed by a single MFSAF v4.0 assessment

during Screening prior to Day BL1.

4. Anemic, defined as a Hgb < 10 g/dL in Screening/Baseline period.

5. 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.

6. 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.

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

DIPSS-plus.

8. No allogeneic stem cell transplant planned.

9. Acceptable laboratory assessments:

- Absolute neutrophil count (ANC) ≥ 0.75 × 10⁹/L.

- Platelet count (PLT) ≥ 25 × 10⁹/L (without requirement for platelet transfusion).

- Peripheral blast count < 10%.

- Alanine aminotransferase/ glutamic-oxaloacetic transaminase (AST/SGOT) and

alanine aminotransferase/ serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 3 ×

ULN (≤ 5 × ULN if liver is involved by extramedullary hematopoiesis as judged by

the investigator or if related to iron chelator therapy that was started within

the prior 60 days).

- Calculated creatinine clearance (CCr) ≥ 30 mL/min according to Cockcroft-Gault.

- Direct bilirubin ≤ 2.0 × ULN.

Exclusion Criteria:

1. Use of the following treatments within the time periods noted:

1. Prior momelotinib treatment at any time.

2. Approved JAK inhibitor therapy (eg, fedratinib or ruxolitinib) within 1 week

prior to the first day of Baseline.

3. Active anti-MF therapy within 1 week prior to the first day of Baseline.

4. Potent Cytochrome P450 3A4 (CYP3A4) inducers within 1 week prior to

Randomization.

5. Investigational agent (including investigational JAK inhibitors) within 4 weeks

prior to Randomization.

6. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to Randomization.

7. Danazol within 3 months prior to Randomization.

8. Splenic irradiation within 3 months prior to Randomization.

9. Current treatment with simvastatin, atorvastatin, lovastatin or rosuvastatin.

2. 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.

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

4. 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.

5. Any of the following (criteria a - k):

1. 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).

2. Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology

Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization.

3. Unstable angina pectoris within 6 months prior to Randomization.

4. Symptomatic congestive heart failure within 6 months prior to Randomization.

5. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization.

6. QTcF interval > 500 msec, unless attributed to bundle branch block.

7. Current progressive thrombosis despite treatment.

8. History of porphyria.

9. Child-Pugh score ≥ 10.

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.

11. Inability or unwillingness to comply with the protocol restrictions on MF therapy

and other medications prior to and during study treatment.

6. Subjects 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.

7. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies,

or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or

thalassemia.

8. Known positive status for HIV.

9. Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C

carrier (testing required for hepatitis B and C).

10. Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per

CTCAE v5.0.

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

12. Women who are already pregnant or lactating.

Additional inclusion/exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Total Symptom Score (TSS) response rate at Week 24 measured using the Myelofibrosis Symptom Assessment Form v4.0 (Time Frame - Week 24 landmark.):
Difference in TSS response rate at Week 24. TSS response is defined as the proportion of subjects who achieve a ≥ 50% reduction in TSS over the 28 days immediately prior to the end of Week 24 compared to baseline



Secondary outcome:

1. Transfusion independence (TI) status at Week 24 (Time Frame - Week 24 landmark.):
Proportion of subjects with TI status at the end of Week 24. TI is defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥ 12 weeks immediately prior to the end of Week 24, with Hgb levels ≥ 8 g/dL.

2. Splenic response rate (SRR) at Week 24 (Time Frame - Week 24):
Proportion of subjects who have splenic response (reduction in spleen volume of ≥ 35% from baseline) at the end of Week 24

Studien-Arme

  • Experimental: Momelotinib
    Participants will receive momelotinib plus placebo to match danazol
  • Active Comparator: Danazol
    Participants will receive danazol plus placebo to match momelotinib

Geprüfte Regime

  • Momelotinib (MMB, GS-0387, CYT387):
    Momelotinib tablets will be self-administered orally once daily
  • Danazol (Danocrine):
    Danazol capsules will be self-administered orally twice daily
  • Placebo to match momelotinib:
    Momelotinib placebo tablets will be self-administered orally once daily
  • Placebo to match danazol:
    Danazol placebo capsules will be self-administered orally twice daily

Quelle: ClinicalTrials.gov


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