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Tyrosine Kinase Inhibitor

Fostamatinib for Myelofibrosis

Phase 2
Waitlist Available
Led By Amy Zhou, M.D.
Research Sponsored by Washington University School of Medicine
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 from start of treatment through 30 days after last day of study treatment (estimated to be approximately 16 weeks)
Awards & highlights

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
  • Low Platelet Count

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through 30 days after last day of study treatment (estimated to be approximately 40 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment through 30 days after last day of study treatment (estimated to be approximately 40 weeks) 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 With a Platelet Response (Part A)
Toxicity of Fostamatinib and Ruxolitinib Treatment (Part B)
Secondary outcome measures
Change in Marrow Fibrosis by WHO Grading (Part B)
Change in Mean Spleen Volume as Determined by Ultrasound at Week 12 of Fostamatinib Treatment (Part A)
Duration of Uninterrupted Ruxolitinib Treatment (Part B)
+13 more

Side effects data

From 2013 Phase 2 trial • 101 Patients • NCT01499303
24%
BLOOD ALKALINE PHOSPHATASE INCREASED
24%
NEUTROPENIA
24%
THROMBOCYTOPENIA
19%
NAUSEA
19%
ASPARTATE AMINOTRANSFERASE INCREASED
19%
FATIGUE
19%
CONSTIPATION
19%
BACK PAIN
19%
PYREXIA
19%
COUGH
14%
DIARRHOEA
14%
DYSPNOEA
14%
BLOOD CREATININE INCREASED
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
BLOOD BILIRUBIN INCREASED
10%
ANAEMIA
10%
ABDOMINAL DISTENSION
10%
HEADACHE
10%
OEDEMA PERIPHERAL
10%
BLOOD UREA INCREASED
10%
HYPOTENSION
10%
ARTHRALGIA
10%
ANXIETY
10%
NEUTROPHIL COUNT DECREASED
5%
HYPERTENSION
5%
ABDOMINAL PAIN
5%
WHITE BLOOD CELL COUNT DECREASED
5%
HYPONATRAEMIA
5%
BLOOD LACTATE DEHYDROGENASE INCREASED
5%
MYALGIA
5%
NEUTROPENIC SEPSIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
100mg BID
200mg BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Fostamatinib + RuxolitinibExperimental Treatment2 Interventions
After 3 cycles of fostamatinib monotherapy, all patients with a sustained platelet count ≥ 50K/microL, will continue on the current fostamatinib dose plus ruxolitinib at the recommended dose per standard prescribing guidelines for an additional 9 cycles. Patients who do not reach platelet count of at least 50K/microL but who achieve clinical benefit per the treating provider may continue on single agent fostamatinib for up to 12 total treatment cycles. If these patients achieve a sustained platelet count of ≥ 50K/microL at any point prior to Cycle 10 Day 1, then they may be eligible to enroll in Part B of the study and continue treatment with fostamatinib and ruxolitinib for the remainder of the study.
Group II: Part A: FostamatinibExperimental Treatment1 Intervention
The starting dose of fostamatinib is 100 mg twice daily (BID). After the first cycle, if no major dose related safety issue is observed and the platelet count is less than 50K/microL, then the fostamatinib dose will be increased to 150 mg BID for the next 2 cycles; otherwise the dose may be continued at 100 mg BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fostamatinib
2010
Completed Phase 3
~1510
Ruxolitinib
2018
Completed Phase 3
~1140

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsIndustry Sponsor
31 Previous Clinical Trials
3,845 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,706 Total Patients Enrolled
Amy Zhou, M.D.Principal InvestigatorWashington University School of Medicine

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia
2021. "Fostamatinib as a Single Agent or in Combination With Ruxolitinib for Treatment of Patients With Myelofibrosis With Severe Thrombocytopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543279.
~1 spots leftby Apr 2025
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