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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%
Diarrhoea
69%
Hypertension
57%
Decreased appetite
54%
Weight decreased
49%
Nausea
44%
Fatigue
40%
Headache
38%
Proteinuria
38%
Vomiting
38%
Stomatitis
33%
Palmar-plantar erythrodysaesthesia syndrome
33%
Arthralgia
33%
Dysphonia
32%
Constipation
30%
Cough
26%
Asthenia
25%
Oedema peripheral
21%
Rash
20%
Back pain
20%
Myalgia
19%
Abdominal pain
18%
Pain in extremity
18%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Anaemia
12%
Musculoskeletal chest pain
12%
Dry skin
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Thrombocytopenia
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Hypomagnesaemia
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
7%
Hyponatraemia
7%
Ejection fraction decreased
7%
Haematuria
7%
Malaise
7%
Blood thyroid stimulating hormone increased
7%
Platelet count decreased
7%
Aspartate aminotransferase increased
7%
Toothache
7%
Glossodynia
7%
Blood alkaline phosphatase increased
7%
Hyperkeratosis
7%
Bronchitis
7%
Pruritus
6%
Influenza
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Dysuria
5%
Paraesthesia
5%
Non-cardiac chest pain
5%
Productive cough
5%
Hypothyroidism
5%
Haemoptysis
5%
White blood cell count decreased
5%
Pneumonia
3%
General physical health deterioration
2%
Sepsis
2%
Cholecystitis
2%
Pulmonary embolism
2%
seizure
2%
Acute myocardial infarction
2%
Atrial fibrillation
2%
Lower respiratory tract infection
2%
Hypotension
2%
Lung infection
2%
Malignant pleural effusion
2%
Spinal cord compression
2%
Acute kidney injury
1%
Acute coronary syndrome
1%
Blood uric acid increased
1%
Death
1%
Monoparesis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Intestinal obstruction
1%
Osteoarthritis
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Pneumatosis intestinalis
1%
Cerebrovascular accident
1%
Confusional state
1%
Hepatic failure
1%
Liver injury
1%
Diverticulitis
1%
Appendicitis
1%
Bacteraemia
1%
Gastroenteritis
1%
Perineal abscess
1%
Wound infection
1%
Intracranial tumour haemorrhage
1%
Malignant neoplasm progression
1%
Bone pain
1%
Cancer pain
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 20 mg
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
515 Previous Clinical Trials
153,893 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,695 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,444 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: Ewing Sarcoma
- Group 3: Diffuse Midline Glioma
- Group 4: Medulloblastoma
- Group 5: Ependymoma
- 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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