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Tyrosine Kinase Inhibitor

Fostamatinib for Sickle Cell Disease

Phase 1

Waitlist Available

Led By Arun S Shet, M.D.

Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)

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 baseline (day 0) to end of study (day 70)

Awards & highlights

Study Summary

This trial will test a drug (fostamatinib) in people with sickle cell disease to see if it can treat blood clots without causing increased bleeding. People aged 18-65 with SCD can participate.

Who is the study for?

Adults aged 18-65 with stable Sickle Cell Anemia (SCA) who haven't had a blood transfusion in the last 12 weeks. Participants must not be pregnant, agree to use two forms of contraception, and have normal organ function. They can't join if they have certain medical conditions like uncontrolled hypertension, active infections, or history of malignancy.Check my eligibility

What is being tested?

The trial is testing Fostamatinib's safety and how well people with SCA tolerate different doses. Over 12 weeks, participants will take the drug orally twice daily for up to six weeks and attend clinic visits every two weeks to monitor effects and possibly increase dosage based on tolerance.See study design

What are the potential side effects?

Potential side effects include digestive issues, liver problems indicated by changes in specific blood tests (AST/ALT levels), lowered white blood cell counts which could raise infection risk, anemia symptoms worsening if hemoglobin drops too low, or bleeding complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0) to end of study (day 70)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0) to end of study (day 70)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0) to end of study (day 70) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The number of type, incidence, severity and relationship to study treatment of adverse events and serious adverse events

Secondary outcome measures

Number of participants that discontinued fostamatinib due to adverse events following CTCAE.

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

HYPERTENSION

ABDOMINAL PAIN

WHITE BLOOD CELL COUNT DECREASED

HYPONATRAEMIA

BLOOD LACTATE DEHYDROGENASE INCREASED

MYALGIA

NEUTROPENIC SEPSIS

100%

80%

60%

40%

20%

Study treatment Arm

100mg BID

200mg BID

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fostamatinib in participants with Sickle Cell DiseaseExperimental Treatment1 Intervention

Participants with Sickle Cell Disease will receive Fostamatinib which will be administered orally, at a dose of 100 mg twice a day for 14 days and if tolerated, will be escalated to a dose of 150 mg, taken orally, twice a day for 28 days (total 42 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fostamatinib

2010

Completed Phase 3

~1510

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor

3,836 Previous Clinical Trials

47,851,028 Total Patients Enrolled

Arun S Shet, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

4 Previous Clinical Trials

2,196 Total Patients Enrolled

Swee Lay Thein, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)

12 Previous Clinical Trials

7,900 Total Patients Enrolled

Media Library

Fostamatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05904093 — Phase 1

Sickle Cell Disease Research Study Groups: Fostamatinib in participants with Sickle Cell Disease

Sickle Cell Disease Clinical Trial 2023: Fostamatinib Highlights & Side Effects. Trial Name: NCT05904093 — Phase 1

Fostamatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05904093 — Phase 1

Frequently Asked Questions

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

Has the federal government given their sanction to Fostamatinib for treating individuals with Sickle Cell Disease?

"Due to limited data regarding safety and efficacy, Fostamatinib's score on the safety scale was a 1."

Answered by AI

Does this trial allow elderly individuals to participate?

"As specified in the eligibility criteria, this medical trial is open to participants aged between 18 and 65."

Answered by AI

What are the requirements for taking part in this clinical trial?

"To be eligible for the clinical trial, applicants must have a diagnosis of sickle cell disease and fit within an age range of 18 to 65. At maximum capacity, 20 individuals will participate in this experiment."

Answered by AI

Is recruitment for this experiment still open?

"According to clinicaltrials.gov, the recruitment phase for this trial has already concluded as it was last edited on June 14th 2023. Nonetheless, there are 237 other trials open and actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease

2024. "Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05904093.

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