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mTOR Inhibitor

Lenvatinib for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Eisai Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug until pd or death, whichever occurred first (up to 16.5 months)
Awards & highlights

Study Summary

This trial will test if the combination of lenvatinib and everolimus is safe and effective in treating pediatric patients with recurrent/refractory solid tumors, including Ewing sarcoma/peripheral primitive neuroectodermal tumor (pPNET), rhabdomyosarcoma, and high grade glioma (HGG).

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug until pd or death, whichever occurred first (up to 16.5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug until pd or death, whichever occurred first (up to 16.5 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)
+2 more
Secondary outcome measures
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Lenvatinib (AUC[0-t Hours])
Phase 1: Clinical Benefit Rate (CBR)
Phase 1: Disease Control Rate (DCR)
+11 more

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554
70%
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%
Oral pain
10%
Thrombocytopenia
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%
Hypercalcaemia
1%
Intestinal obstruction
1%
Blood uric acid increased
1%
Death
1%
Small intestinal obstruction
1%
Monoparesis
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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: Cohort 3, High Grade Glioma (HGG)Experimental Treatment2 Interventions
During Phase 2 (four 28-day cycles [up to 16 weeks of treatment]), utilizing Simon's optimal 2-stage design, participants with recurrent or refractory HGG (Cohort 3) will receive the RP2D of lenvatinib in combination with everolimus determined in Phase 1 (1 cycle; 4 weeks). Participants who discontinue study treatment before completing 4 cycles will transition to the Off-treatment Visit. Participants who complete 4 cycles will transition to the Extension Phase, in which they will continue to receive the same study treatment in 28-day cycles.
Group II: Phase 2: Cohort 2, RhabdomyosarcomaExperimental Treatment2 Interventions
During Phase 2 (four 28-day cycles [up to 16 weeks of treatment]), utilizing Simon's optimal 2-stage design, participants with recurrent or refractory rhabdomyosarcoma (Cohort 2) will receive the RP2D of lenvatinib in combination with everolimus determined in Phase 1 (1 cycle; 4 weeks of treatment). Participants who discontinue study treatment before completing 4 cycles will transition to the Off-treatment Visit. Participants who complete 4 cycles will transition to the Extension Phase, in which they will continue to receive the same study treatment in 28-day cycles.
Group III: Phase 2: Cohort 1, Ewing sarcomaExperimental Treatment2 Interventions
During Phase 2 (four 28-day cycles [up to 16 weeks of treatment]), utilizing Simon's optimal 2-stage design, participants with recurrent or refractory Ewing sarcoma (Cohort 1) will receive the RP2D of lenvatinib in combination with everolimus determined in Phase 1. Participants who discontinue study treatment before completing 4 cycles will transition to the Off-treatment Visit. Participants who complete 4 cycles will transition to the Extension Phase, in which they will continue to receive the same study treatment in 28-day cycles.
Group IV: Phase 1: Phase 1; Recurrent or refractory solid tumorsExperimental Treatment2 Interventions
During Phase 1 (Treatment Phase: 1 cycle; 28 days of treatment), utilizing a rolling 6 design, participants with recurrent or refractory solid tumors will receive escalating doses of lenvatinib in combination with everolimus for determination of the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Participants who complete 1 cycle of treatment will transition to the Extension Phase, in which they will continue to receive the same study treatment in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
154,021 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,878 Previous Clinical Trials
5,053,133 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
2017. "Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03245151.
~9 spots leftby Apr 2025
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