← Back to Search

JAK Inhibitor

MMB for Myelofibrosis

Phase 2

Waitlist Available

Research Sponsored by Sierra Oncology LLC - a GSK company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed every 12 weeks until discontinuation. participation in this extended access study has been an average of approximately 8 months.

Awards & highlights

Study Summary

This trial is testing the safety of a drug called momelotinib for people with myelofibrosis, a bone marrow disorder.

Who is the study for?

This trial is for adults with myelofibrosis who are already participating in specific earlier studies of momelotinib (MMB). They must understand and agree to the study's terms. People allergic to MMB or its ingredients cannot join.Check my eligibility

What is being tested?

The trial provides continued access to MMB for patients from previous trials, assessing long-term safety. It also looks at how well participants live without their disease getting worse or developing into leukemia.See study design

What are the potential side effects?

While not explicitly listed here, side effects may include those commonly associated with cancer treatments such as fatigue, nausea, and potential blood-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed every 12 weeks until discontinuation. participation in this extended access study has been an average of approximately 8 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed every 12 weeks until discontinuation. participation in this extended access study has been an average of approximately 8 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed every 12 weeks until discontinuation. participation in this extended access study has been an average of approximately 8 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Had Access to, and Received the Intervention

Side effects data

From 2017 Phase 2 trial • 41 Patients • NCT02515630

29%

Cough

24%

Diarrhoea

22%

Nausea

20%

Fatigue

17%

Pruritus

17%

Vomiting

17%

Thrombocytopenia

15%

Dizziness

15%

Headache

15%

Abdominal pain

15%

Urinary tract infection

12%

Dyspnoea

12%

Contusion

12%

Neutropenia

10%

Hyperuricaemia

10%

Fall

10%

Decreased appetite

Blood creatinine increased

Acute kidney injury

Constipation

Nasal congestion

Peripheral sensory neuropathy

Chills

Pollakiuria

Hypotension

Night sweats

Anemia

Musculoskeletal pain

Presyncope

Lung infection

Death

Pyrexia

Atrial fibrillation

Cardiac arrest

Small intestinal obstruction

Acute respiratory failure

Respiratory failure

Cholecystitis

Transfusion reaction

Hepatic enzyme increased

Bone pain

Metabolic encephalopathy

Asthenia

Pneumonia

Sepsis

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Momelotinib (MMB)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Study SRA-MMB-301Experimental Treatment1 Intervention

Participants will continue to receive the same dosage regimen as in the previous MMB study SRA-MMB-301 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Group II: Cohort 3: Study GS-US-352-1154Experimental Treatment1 Intervention

Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1154 until MMB receives regulatory approval and is commercially available, or development of the product ceases..

Group III: Cohort 2: Study GS-US-352-1214Experimental Treatment1 Intervention

Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-1214 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Group IV: Cohort 1: Study GS-US-352-0101Experimental Treatment1 Intervention

Participants will continue to receive the same dosage regimen as in the previous MMB study GS-US-352-0101 until MMB receives regulatory approval and is commercially available, or development of the product ceases.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MMB

2016

Completed Phase 2

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sierra Oncology LLC - a GSK companyLead Sponsor

19 Previous Clinical Trials

1,715 Total Patients Enrolled

8 Trials studying Primary Myelofibrosis

1,258 Patients Enrolled for Primary Myelofibrosis

GlaxoSmithKlineLead Sponsor

4,751 Previous Clinical Trials

8,067,235 Total Patients Enrolled

1 Trials studying Primary Myelofibrosis

Sierra Oncology, Inc.Lead Sponsor

19 Previous Clinical Trials

1,715 Total Patients Enrolled

8 Trials studying Primary Myelofibrosis

1,258 Patients Enrolled for Primary Myelofibrosis

Media Library

Momelotinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03441113 — Phase 2

Primary Myelofibrosis Research Study Groups: Cohort 1: Study GS-US-352-0101, Cohort 2: Study GS-US-352-1214, Cohort 3: Study GS-US-352-1154, Cohort 4: Study SRA-MMB-301

Primary Myelofibrosis Clinical Trial 2023: Momelotinib Highlights & Side Effects. Trial Name: NCT03441113 — Phase 2

Momelotinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03441113 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial a pioneering endeavor?

"As of today, 2 clinical trials related to this treatment exist across 116 cities and 23 countries. The original study was initiated in 2018, sponsored by Sierra Oncology, Inc., with 400 participants that progressed through Phase 2 drug approval process. To date 7 studies have been finished since the initial research commenced two years ago."

Answered by AI

Are there any vacancies available for individuals interested in participating in this research?

"Contrary to expectations, this clinical trial is not accepting new participants at present. It was initially posted on May 3rd 2018 and edited as recently as September 19th 2022; however there are presently 126 other studies needing patients around the world."

Answered by AI

How hazardous is this therapeutic approach for those receiving it?

"Our internal assessment of this treatment's safety is a 2. This rating comes as the trial has only reached Phase Two, with limited evidence in regards to efficacy and some preliminary data suggesting safety."

Answered by AI

How many participants are currently taking part in the research?

"Presently, this clinical trial is not accepting new applicants. It was initially advertised on May 3rd 2018 and its information last updated on September 19th 2022. For those searching for alternative studies that are actively recruiting participants with post-polycythemia vera myelofibrosis (post-pv mf), there are currently 124 trials open to applicants and 2 of those trials involve the proposed treatment."

Answered by AI

Are multiple medical centers in this state hosting the trial?

"This study has 18 active clinical sites, such as Washington University School of Medicine Siteman Cancer Center in St. Louis, Winship Cancer Institute and Emory University in Atlanta along with Northwest Oncology & Hematology - Rolling Meadows in Rolling Meadows. Additionally there are multiple other locations participating."

Answered by AI

What prior experience has this therapeutic intervention had in clinical trials?

"This therapy was first examined at Gentofte Hospital in 2018 and there have been 7 trials concluded since then. Of the two active clinical tests, many are taking place around Saint Louis, Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extended Access of Momelotinib in Adults With Myelofibrosis

2018. "Extended Access of Momelotinib in Adults With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03441113.

All > Essential Thrombocythemia > Polycythemia Vera