All > Thrombocytopenia > Myelofibrosis

Fostamatinib for Myelofibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MOMyelofibrosisFostamatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial suggests that the drug Fostamatinib may help improve the condition of myelofibrosis patients who have severe thrombocytopenia. Additionally, the drug may help improve symptoms and splenomegaly related to myelofibrosis.

Eligible Conditions
  • Myelofibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 16 Secondary · Reporting Duration: From start of treatment through 30 days after last day of study treatment (estimated to be approximately 40 weeks)

Week 36
Change in marrow fibrosis by WHO grading (Part B)
Mean reduction in spleen volume as determined by ultrasound after 12 weeks of combination treatment (Part B)
Number of participants with 35% or greater reduction in spleen volume as determined by ultrasound after 12 weeks of combination treatment (Part B)
Number of participants with 50% or greater improvement in Total Symptom Score (Part B)
Week 16
Toxicity of fostamatinib treatment (Part A)
Week 40
Toxicity of fostamatinib and ruxolitinib treatment (Part B)
Through 12 weeks
Number of participants who permanently discontinue fostamatinib due to fostamatinib related adverse events(Part A)
Number of participants who require treatment interruption of fostamatinib due to adverse events (Part A)
Number of participants who was dose escalated and tolerated fostamatinib dose greater than 100 mg BID (Part A)
Platelet response (Part A)
Week 12
Number of participants eligible to initiate therapy with ruxolitinib (Part A)
Through week 12
Change in marrow fibrosis by WHO grading (Part A)
Number of participants who achieve platelet transfusion independence (Part A)
Number of participants with anemia who achieve RBC transfusion independence (Part A)
Up to 36 weeks
Duration of uninterrupted ruxolitinib treatment (Part B)
Week 12
Mean reduction is spleen volume as determined by ultrasound at week 12 of fostamatinib treatment (Part A)
Number of participants who achieve 35% or greater reduction in spleen volume as determined by ultrasound at week 12 of fostamatinib treatment (Part A)
Number of participants with 50% or greater improvement in Total Symptom Score (Part A)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
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1
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Side Effects for

100mg BID
24%NEUTROPENIA
24%THROMBOCYTOPENIA
24%BLOOD ALKALINE PHOSPHATASE INCREASED
19%PYREXIA
19%ASPARTATE AMINOTRANSFERASE INCREASED
19%FATIGUE
19%COUGH
19%NAUSEA
19%CONSTIPATION
19%BACK PAIN
14%DIARRHOEA
14%DYSPNOEA
14%BLOOD CREATININE INCREASED
14%ALANINE AMINOTRANSFERASE INCREASED
14%BLOOD BILIRUBIN INCREASED
10%ARTHRALGIA
10%ANXIETY
10%HYPOTENSION
10%OEDEMA PERIPHERAL
10%HEADACHE
10%ABDOMINAL DISTENSION
10%BLOOD UREA INCREASED
10%ANAEMIA
10%NEUTROPHIL COUNT DECREASED
5%MYALGIA
5%BLOOD LACTATE DEHYDROGENASE INCREASED
5%ABDOMINAL PAIN
5%HYPERTENSION
5%NEUTROPENIC SEPSIS
5%HYPONATRAEMIA
5%WHITE BLOOD CELL COUNT DECREASED
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01499303) in the 100mg BID ARM group. Side effects include: NEUTROPENIA with 24%, THROMBOCYTOPENIA with 24%, BLOOD ALKALINE PHOSPHATASE INCREASED with 24%, PYREXIA with 19%, ASPARTATE AMINOTRANSFERASE INCREASED with 19%.

Trial Design

2 Treatment Groups

Part B: Fostamatinib + Ruxolitinib
1 of 2
Part A: Fostamatinib
1 of 2

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Fostamatinib · No Placebo Group · Phase 2

Part B: Fostamatinib + RuxolitinibExperimental Group · 2 Interventions: Fostamatinib, Ruxolitinib · Intervention Types: Drug, Drug
Part A: Fostamatinib
Drug
Experimental Group · 1 Intervention: Fostamatinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fostamatinib
FDA approved
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start of treatment through 30 days after last day of study treatment (estimated to be approximately 40 weeks)

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,284,082 Total Patients Enrolled
Rigel PharmaceuticalsIndustry Sponsor
28 Previous Clinical Trials
3,421 Total Patients Enrolled
Amy Zhou, M.D.Principal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

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References

Frequently Asked Questions

How many people are able to join this clinical trial?

"Yes, according to the latest update on clinicaltrials.gov, this study is currently looking for 12 patients from 1 site. The trial was originally posted on May 3rd, 2021 and was most recently updated on October 26th, 2022." - Anonymous Online Contributor

Unverified Answer

What are the primary maladies that Fostamatinib has been shown to improve?

"Fostamatinib is an effective therapeutic procedure for patients struggling with polycythemia vera or polycythemia." - Anonymous Online Contributor

Unverified Answer

Are new patients still being taken in for this experiment?

"The trial, which was first posted on 5/3/2021 and last edited on 10/26/2022, is looking for patients that meet the requirements specified." - Anonymous Online Contributor

Unverified Answer

Has Fostamatinib been cleared by the FDA?

"Fostamatinib's safety is based on data from Phase 2 trials, which only provides limited evidence. Therefore, it receives a score of 2." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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