Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Fostamatinib for Leukemia
Phase 1
Recruiting
Led By Guillermo M Bravo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Both females of childbearing potential and males with female partners of childbearing potential must agree to use contraception during the study period and for at least one month after the last dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a drug to treat cancer patients who have failed other therapies. The drug may stop the growth of tumor cells by blocking enzymes needed for cell growth.
Who is the study for?
Adults with lower-risk myelodysplastic syndromes or chronic myelomonocytic leukemia who didn't improve after treatment with hypomethylating agents. They must have had at least 4 cycles of such therapy, not be pregnant or breastfeeding, able to consent, and willing to use contraception. Excluded are those with very low white blood cells, uncontrolled high blood pressure, other recent cancers (with some exceptions), or recent stem cell transplants.Check my eligibility
What is being tested?
The trial is testing fostamatinib's effectiveness and optimal dosage for patients whose tumor growth hasn't been halted by standard treatments. It works by blocking enzymes that cancer cells need to grow.See study design
What are the potential side effects?
While the specific side effects of fostamatinib in this context aren't listed here, common ones may include diarrhea, high blood pressure, nausea, fatigue and liver enzyme elevations. Each patient's experience can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I agree to use contraception during and for a month after the study.
Select...
I have MDS or CMML and my risk level is not high according to IPSS-R.
Select...
I am 18 years old or older.
Select...
My kidneys work well enough (creatinine clearance over 30 mL/min).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The PI doesnt wish to add any Outcome Measures this will be add at the time of results
Side effects data
From 2013 Phase 2 trial • 101 Patients • NCT0149930324%
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
1Treatment groups
Experimental Treatment
Group I: Treatment (fostamatinib)Experimental Treatment1 Intervention
Patients receive fostamatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles (week 24) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fostamatinib
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,297 Total Patients Enrolled
166 Trials studying Myelodysplastic Syndromes
10,605 Patients Enrolled for Myelodysplastic Syndromes
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,628 Total Patients Enrolled
538 Trials studying Myelodysplastic Syndromes
91,261 Patients Enrolled for Myelodysplastic Syndromes
Guillermo M BravoPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
204 Total Patients Enrolled
3 Trials studying Myelodysplastic Syndromes
140 Patients Enrolled for Myelodysplastic Syndromes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer in the last 2 years, except for certain skin cancers or cervical cancer.I can take hydroxyurea for white blood cell control if needed.I can take care of myself and am up and about more than half of my waking hours.I have needed a blood or platelet transfusion in the last 28 days.I agree to use contraception during and for a month after the study.I am a woman who can have children and have not had a negative pregnancy test.My condition did not improve after treatment with specific drugs for blood disorders.My blood pressure is high, above 135/85 mmHg, even with treatment.I am not pregnant or breastfeeding.I have had a stem cell transplant or am on immunosuppressants due to it within the last 6 months.I have MDS or CMML and my risk level is not high according to IPSS-R.I am 18 years old or older.I am not currently on any experimental treatments or had chemotherapy, radiotherapy, or immunotherapy in the last 14 days.I have not received any treatment for my MDS or CMML.I have an infection that isn't getting better with antibiotics.I am willing to use effective birth control during the study.My kidneys work well enough (creatinine clearance over 30 mL/min).
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (fostamatinib)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored for this research initiative?
"Affirmative. Clinicaltrials.gov reflects this medical trial's current search for participants, which started on August 13th 2021 and was most recently updated on September 22nd 2022. The research involves 20 individuals across a single site."
Answered by AI
Is it still possible to volunteer for this research endeavor?
"This clinical trial is actively enrolling, having been first posted on August 13th 2021 and more recently updated on September 22nd 2022."
Answered by AI
Has this particular experiment been attempted before?
"Research into Fostamatinib commenced in 2018, when the first trial sponsored by Rigel Pharmaceuticals was completed. After successful Phase 1 testing involving 27 people, this drug has been studied further and 6 ongoing trials are being conducted across 18 countries and 58 cities."
Answered by AI
What is the regulatory status of Fostamatinib?
"Fostamatinib's safety is currently based on limited data, which places it at a score of 1. As this trial is only in its first phase, there are not yet many studies to support either its efficacy or safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger