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Splicing Modulator
E7820 for Leukemia
Phase 2
Waitlist Available
Led By Eytan Stein, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Refractory CMML is defined as: Failure to achieve a response (as per IWG 2006 criteria) after 4 cycles of HMA monotherapy or 2 cycles of HMA + venetoclax.
Relapsed CMML is defined as: Any relapse after achieving an IWG defined response.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether E7820 is an effective treatment for myeloid cancers that have relapsed or are resistant to other treatments.
Who is the study for?
Adults with relapsed or refractory myeloid cancers, specifically AML, MDS, or CMML that have certain splicing factor gene mutations. They must have tried specific treatments without success and should not be pregnant or breastfeeding. Participants need to be in a stable enough condition to follow the study schedule.Check my eligibility
What is being tested?
The trial is testing E7820's effectiveness for those with myeloid cancers who've had previous treatment failures. It focuses on patients whose cancer has returned after remission or hasn't responded to standard therapies.See study design
What are the potential side effects?
While the specific side effects of E7820 are not listed here, similar medications often cause fatigue, nausea, increased risk of infection due to low blood cell counts, bleeding complications, and potential liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My CMML did not improve after specific treatments.
Select...
My CMML cancer has returned after initially responding to treatment.
Select...
I am 18 years old or older.
Select...
My blood cancer has returned or didn't respond to treatment, and I have a specific genetic mutation.
Select...
My kidney function is good and my liver is not severely damaged.
Select...
My MDS has returned after initially responding to treatment.
Select...
My AML has returned after initial treatment success.
Select...
I have tried and cannot tolerate approved treatments for my FLT3, IDH1, or IDH2 mutation.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
My AML did not respond to at least two treatment cycles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
response rate
Side effects data
From 2017 Phase 1 trial • 45 Patients • NCT0177342153%
Fatigue
53%
Diarrhoea
42%
Anaemia
37%
Decreased appetite
37%
Lethargy
37%
Constipation
32%
Insomnia
32%
Abdominal pain
32%
Dizziness
26%
Vomiting
26%
Nausea
26%
Weight decreased
21%
Pyrexia
21%
Back pain
16%
Blood alkaline phosphatase increased
16%
Oedema peripheral
16%
Hyperglycaemia
16%
Headache
16%
Cough
16%
Rash
16%
Musculoskeletal chest pain
16%
Alanine aminotransferase increased
16%
Dry skin
11%
Tachycardia
11%
Gastroenteritis
11%
Upper respiratory tract infection
11%
Dyspnoea
11%
Nasopharyngitis
11%
Urinary tract infection
11%
Aspartate aminotransferase increased
11%
Blood albumin decreased
11%
Hypokalaemia
11%
Hypomagnesaemia
11%
Hyponatraemia
11%
Muscle spasms
11%
Myalgia
11%
Epistaxis
11%
Decubitus ulcer
11%
Hypertension
11%
Abdominal discomfort
11%
Dyspepsia
11%
Lower respiratory tract infection
11%
Ascites
5%
Skin lesion
5%
Tinnitus
5%
Pancreatic enzyme abnormality
5%
Necrosis
5%
Osteomyelitis
5%
Blood thyroid stimulating hormone increased
5%
Pain in extremity
5%
Phlebitis
5%
Inappropriate antidiuretic hormone secretion
5%
Rash pustular
5%
Haematuria
5%
Thirst
5%
Myopathy
5%
Paraesthesia
5%
Bladder spasm
5%
Erysipelas
5%
Urosepsis
5%
Hepatic enzyme abnormal
5%
Tumour haemorrhage
5%
Pruritus
5%
Orthostatic hypotension
5%
Muscle abscess
5%
Atrioventricular block
5%
Hyperthyroidism
5%
Conjunctivitis
5%
Clostridium difficile infection
5%
Gastrooesophageal reflux disease
5%
Pancreatitis
5%
Upper gastrointestinal haemorrhage
5%
Chest discomfort
5%
Facial pain
5%
Influenza like illness
5%
Local swelling
5%
Malaise
5%
Nail infection
5%
Oral herpes
5%
Skin infection
5%
Contusion
5%
Wound haemorrhage
5%
Blood glucose increased
5%
Blood lactate dehydrogenase increased
5%
Blood potassium decreased
5%
Gamma-glutamyltransferase increased
5%
Lipase increased
5%
Protein total decreased
5%
Vitamin D decreased
5%
Dehydration
5%
Type 2 diabetes mellitus
5%
Arthralgia
5%
Arthritis
5%
Bone pain
5%
Bursitis
5%
Musculoskeletal pain
5%
Dizziness postural
5%
Affect lability
5%
Dysphonia
5%
Dyspnoea exertional
5%
Wheezing
5%
Erythema
5%
Night sweats
5%
Onychomadesis
5%
Skin fissures
5%
Haemoptysis
5%
Blood phosphorus decreased
5%
Thrombocytopenia
5%
Feeling cold
5%
Blood bilirubin increased
5%
Cognitive disorder
5%
Neuralgia
5%
Scab
5%
Dysphagia
5%
Hypothyroidism
5%
Abdominal distension
5%
Duodenal ulcer haemorrhage
5%
Pulmonary embolism
5%
Asthenia
5%
Otitis media
5%
Fall
5%
Procedural hypotension
5%
Blood cholesterol increased
5%
Hypocalcaemia
5%
Anxiety
5%
Nipple pain
5%
Haemorrhage
5%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment and Extension Phase Part B: E7820 50 mg
Extension Phase Part A: E7820 100 mg
Treatment and Extension Phase Part B: E7820 60 mg
Treatment Phase Part A: E7820 50 mg Fed
Treatment Phase Part A: E7820 50 mg Fasted
Trial Design
1Treatment groups
Experimental Treatment
Group I: E7820Experimental Treatment1 Intervention
Each patient will receive daily administration of E7820. The starting dose for every patient will be 100 mg daily but the dose can subsequently be reduced if excessive toxicity is encountered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
E7820
2011
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
159,024 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,308 Total Patients Enrolled
Eytan Stein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's electrical activity is irregular or I have a family history of similar issues.My CMML did not improve after specific treatments.My CMML cancer has returned after initially responding to treatment.I haven't had serious heart issues like heart failure, heart attack, or stroke in the last 6 months.I am 18 years old or older.I am currently pregnant or breastfeeding.My blood cancer has returned or didn't respond to treatment, and I have a specific genetic mutation.My liver and kidney functions are within the required range for the trial.I have a condition that affects my ability to swallow or absorb pills.My kidney function is good and my liver is not severely damaged.I have been diagnosed with acute promyelocytic leukemia.You are allergic to sulfa medications.My MDS has returned after initially responding to treatment.I can join regardless of needing blood transfusions or growth support.I have an ongoing infection that hasn't improved with treatment.I have HIV, HBV, or HCV, but my HIV is under control with medication.My AML has returned after initial treatment success.I have tried and cannot tolerate approved treatments for my FLT3, IDH1, or IDH2 mutation.My MDS has not improved after standard treatments.I can care for myself but may not be able to do heavy physical work.I am not pregnant and will use birth control during and 4 months after the study.I have severe, life-threatening complications from my blood cancer.My AML did not respond to at least two treatment cycles.
Research Study Groups:
This trial has the following groups:- Group 1: E7820
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any short-term or long-term risks associated with taking E7820?
"E7820's safety was rated a 2 by our team at Power. This is because, while there is data supporting its safety, there is no information indicating that the medication is effective."
Answered by AI
Are there any other similar ongoing trials to this one?
"E7820 has been under investigation since early 2021. The first 38-person clinical trial was sponsored by Eisai Inc., and after the successful completion of Phase 2, one active trial is currently underway."
Answered by AI
Are there any vacancies open for willing participants in this research?
"That is correct, the website does indicate that the trial is still recruiting patients. The posting dates you mentioned are accurate too. They are looking for a total of 38 individuals across 7 sites."
Answered by AI
How many people are being given this medication as part of the testing process?
"This medical research requires 38 individuals that match the pre-determined inclusion criteria. Those who are interested can go to one of two locations: Memoral Sloan Kettering Basking Ridge in Basking Ridge, New jersey or Memorial Sloan Kettering Nassau in Uniondale, New york."
Answered by AI
What is the efficacy of E7820 in relation to other drugs?
"Currently, there is 1 clinical trial underway for E7820. That active trial is in Phase 3. In addition to the many trials for E7820 based in Miami, Florida, there are 7 other locations running studies for this treatment."
Answered by AI
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