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Tyrosine Kinase Inhibitor
Lenvatinib for Solid Tumors in Pediatric Patients (E7080-G000-231 Trial)
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants >16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment
Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 21 months
Awards & highlights
E7080-G000-231 Trial Summary
This trial is testing a new drug, Lenvatinib, to see if it is effective and safe in treating children, adolescents, and young adults with relapsed or refractory solid malignancies.
Who is the study for?
This trial is for children, adolescents, and young adults with certain types of solid tumors that have come back or didn't respond to treatment. They must be able to perform daily activities at a certain level, have measurable tumor growth, stable organ function including heart and kidneys, controlled blood pressure, no serious infections or HIV, not pregnant or breastfeeding (if applicable), and agree to use contraception.Check my eligibility
What is being tested?
The study tests Lenvatinib's effectiveness in shrinking tumors and its safety in young patients with relapsed/refractory solid malignancies. Participants are grouped based on their specific type of cancer and will receive the drug while being monitored for response.See study design
What are the potential side effects?
Possible side effects include high blood pressure control issues which may require medication adjustments; potential impacts on kidney function; risk of bleeding complications; gastrointestinal disturbances like malabsorption; cardiovascular events such as unstable angina or arrhythmias; neurological changes affecting brain functions.
E7080-G000-231 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities, and if I have a brain tumor, my condition has been stable for at least a week.
Select...
My cancer can be measured using specific criteria.
Select...
I do not have symptoms of severe kidney damage.
Select...
My child's cancer has come back or isn't responding to treatment, and it's not bone cancer.
E7080-G000-231 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
Secondary outcome measures
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
+11 moreSide effects data
From 2019 Phase 3 trial • 392 Patients • NCT0132155470%
Hypertension
70%
Diarrhoea
60%
Weight decreased
43%
Fatigue
43%
Stomatitis
40%
Arthralgia
40%
Proteinuria
40%
Nausea
37%
Decreased appetite
33%
Headache
33%
Asthenia
33%
Dysphonia
30%
Myalgia
30%
Palmar-plantar erythrodysaesthesia syndrome
30%
Abdominal pain upper
30%
Vomiting
27%
Cough
27%
Abdominal pain
27%
Dizziness
23%
Pain in extremity
20%
Alopecia
20%
Back pain
20%
Rash
20%
Dysgeusia
20%
Nasopharyngitis
17%
Constipation
17%
Muscle spasms
17%
Dyspnoea
17%
Epistaxis
17%
Platelet count decreased
17%
Pyrexia
13%
Hypotension
13%
Oropharyngeal pain
13%
Musculoskeletal pain
10%
Anaemia
10%
Paraesthesia
10%
Flank pain
10%
Dyspepsia
10%
Dysphagia
10%
Sinusitis
10%
Oedema peripheral
10%
Pelvic pain
10%
Urinary tract infection
10%
Hypocalcaemia
10%
Musculoskeletal chest pain
10%
Haemoptysis
10%
Depression
10%
Upper respiratory tract infection
10%
Insomnia
7%
Skin fissures
7%
Vitamin D deficiency
7%
Ejection fraction decreased
7%
Pneumonia
7%
Hypomagnesaemia
7%
Joint swelling
7%
Bronchitis
7%
Blood cholesterol increased
7%
Dyspnoea exertional
7%
Hyperhidrosis
7%
Toothache
7%
Hyperaesthesia
7%
Sciatica
7%
Gastrooesophageal reflux disease
7%
Lung infection
7%
Dermatitis acneiform
7%
Hypothyroidism
7%
Alanine aminotransferase increased
7%
Dry skin
7%
Flatulence
7%
Productive cough
7%
Non-cardiac chest pain
7%
Abdominal distension
7%
Gingival pain
7%
Gastrointestinal infection
7%
Pain
7%
Lipase increased
3%
Blood calcium increased
3%
Electrocardiogram T wave inversion
3%
Hypoalbuminaemia
3%
Dementia
3%
Varicose vein
3%
Thermal burn
3%
Blood creatinine increased
3%
Electrocardiogram QT prolonged
3%
Post procedural haemorrhage
3%
Pathological fracture
3%
Syncope
3%
Cerebrovascular accident
3%
Phlebitis infective
3%
Haemorrhoids
3%
Cholecystitis acute
3%
Gastroenteritis
3%
Delirium
3%
General physical health deterioration
3%
Dry mouth
3%
Hyponatraemia
3%
Dehydration
3%
Coronary artery occlusion
3%
Lymph gland infection
3%
Metastatic pain
3%
Transient ischaemic attack
3%
Hydrocholecystis
3%
Vasculitis
3%
Hyperglycaemia
3%
Neck pain
3%
Thrombocytopenia
3%
Malaise
100%
80%
60%
40%
20%
0%
Study treatment Arm
OOL, Treatment Period: Lenvatinib 20 mg
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
E7080-G000-231 Trial Design
7Treatment groups
Experimental Treatment
Group I: RhabdomyosarcomaExperimental Treatment1 Intervention
Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Group II: Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and EpendymomaExperimental Treatment1 Intervention
Participants with other solid tumors will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Group III: MedulloblastomaExperimental Treatment1 Intervention
Participants with medulloblastoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Group IV: High Grade GliomaExperimental Treatment1 Intervention
Participants with high grade glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Group V: Ewing SarcomaExperimental Treatment1 Intervention
Participants with Ewing sarcoma will receive lenvatinib 14 mg/m^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Group VI: EpendymomaExperimental Treatment1 Intervention
Participants with ependymoma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Group VII: Diffuse Midline GliomaExperimental Treatment1 Intervention
Participants with diffuse midline glioma will receive lenvatinib 14 mg/m^2 QD orally until progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,909 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,479 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,896 Previous Clinical Trials
5,062,591 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use contraception and not donate sperm during and for 7 days after treatment.My scans show cancer affecting major blood vessels or has caused holes in the tumor.I have a severe fistula in my GI tract or elsewhere.I am currently being treated for an infection.I have a brain tumor that has bled and caused symptoms.I have brain metastases that have not been treated, except if my cancer started in the brain or its coverings.I have tested positive for hepatitis B or C.I can do most activities, and if I have a brain tumor, my condition has been stable for at least a week.I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.I have a non-healing wound or an open bone fracture.My neurological functions are normal.My heart is functioning well.I have not been in a clinical trial for a new treatment or device in the last 4 weeks.My cancer can be measured using specific criteria.I have recovered from previous cancer treatment side effects, except for hair loss, hearing issues, and mild nerve pain.I am HIV positive.I have had a significant brain bleed detected on an MRI within the last 28 days.I do not have symptoms of severe kidney damage.My child's cancer has come back or isn't responding to treatment, and it's not bone cancer.I have not had significant bleeding from my lungs or GI tract in the last 3 weeks.I haven't had serious heart problems like heart failure or a heart attack in the last 6 months.My blood pressure is under control, with or without medication.I have not had major surgery in the last 3 weeks.My organs are functioning well.You have mental health or substance abuse problems that would make it difficult for you to follow the study's rules and requirements.I have a condition that affects how my body absorbs medication.
Research Study Groups:
This trial has the following groups:- Group 1: Rhabdomyosarcoma
- Group 2: Diffuse Midline Glioma
- Group 3: Ewing Sarcoma
- Group 4: Ependymoma
- Group 5: Medulloblastoma
- Group 6: Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
- Group 7: High Grade Glioma
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 open enrollment slots available for this trial at the moment?
"Confirming the information on clinicaltrials.gov, this medical trial is not presently recruiting patients. The study was initially posted July 30th 2020 and its last update occurred October 10th 2022. Although it has stopped collecting applicants, there are currently 2528 other trials seeking participants."
Answered by AI
Could you elaborate on the other trials which have evaluated Lenvatinib's efficacy?
"Lenvatinib's investigation began in 2016, when Call for Information (Investigational Site 0002) first published a study. Since then, 54 different studies have been completed and 148 are still recruiting patients. Aurora, Colorado has the largest concentration of active research related to lenvatinib."
Answered by AI
What criteria must potential participants meet to be eligible for this research?
"This trial has a participant cap of 127 and is open to patients between the ages of 2 and 21 who have been diagnosed with cancer."
Answered by AI
What is the current number of enrollees in this clinical research endeavor?
"Currently, no patients are being sought for this trial. It was first posted on July 30th 2020 and last modified on October 10th 2022. If you're looking into alternative studies, 2380 investigations with links to cancer are actively recruiting participants along with 148 clinical trials involving lenvatinib."
Answered by AI
Are there multiple sites administering this trial across the state?
"In addition to the initial 3 sites, Children's Hospital of Colorado (Site 0110) in Aurora, CO, Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102) in Nashville, TN and Cleveland Clinic ( Site 0119) in Cleveland, OH are all recruiting participants for this trial."
Answered by AI
Is this trial a distinct or pioneering undertaking?
"Lenvatinib has had a long and successful research history. Initially investigated in 2016 by Merck Sharp & Dohme Corp., the drug obtained Phase 1 approval after examining 576 patients. Currently, there are 148 active studies that span 53 countries and 1017 cities."
Answered by AI
Is elderly participation being accepted in this investigation?
"Eligibility for this clinical trial has a minimum age of two and an upper limit of 21 years."
Answered by AI
What safety considerations should be taken into account when administering Lenvatinib to individuals?
"The safety of lenvatinib was estimated to be a 2, as it has gone through the second stage of clinical trials and there is some evidence confirming its security but none that shows its efficacy."
Answered by AI
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