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Topoisomerase Inhibitor
Lenvatinib for Osteosarcoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Eisai Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with DTC must be receiving thyroxine suppression therapy and levels of thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than or equal to 5.50 milliunits per liter (mU/L)). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH less than 0.50 mU/L).
Histologically or cytologically confirmed diagnosis of solid malignant tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 4 years 7 months
Awards & highlights
Study Summary
This trial is studying if lenvatinib is safe and effective in treating children with solid tumors that have come back or do not respond to treatment.
Eligible Conditions
- Osteosarcoma
- Tumors
- Cancer
- Thyroid Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to approximately 4 years 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 4 years 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Recommended Dose (RD) of Lenvatinib
Cohort 2A: Number of Participants With Best Overall Response (BOR)
Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
+2 moreSecondary outcome measures
Tumor Markers
Cohorts 1, 2A, 2B, 3A and 3B: Duration of Response (DOR)
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
+13 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%
Abdominal pain upper
18%
Musculoskeletal pain
18%
Dry mouth
18%
Dyspnoea
18%
Dysgeusia
18%
Pain in extremity
17%
Dizziness
16%
Pyrexia
16%
Oropharyngeal pain
16%
Hypokalaemia
15%
Hypocalcaemia
15%
Dyspepsia
14%
Epistaxis
13%
Dysphagia
13%
Alopecia
12%
Musculoskeletal chest pain
12%
Dry skin
12%
Anaemia
11%
Urinary tract infection
11%
Nasopharyngitis
10%
Oral pain
10%
Blood creatinine increased
10%
Electrocardiogram QT prolonged
10%
Thrombocytopenia
10%
Hypoalbuminaemia
10%
Upper respiratory tract infection
9%
Dehydration
9%
Neck pain
8%
Influenza like illness
8%
Muscle spasms
8%
Depression
8%
Lymphopenia
8%
Alanine aminotransferase increased
8%
Muscular weakness
8%
Hypomagnesaemia
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%
Ejection fraction decreased
7%
Hyponatraemia
7%
Pruritus
6%
Anxiety
6%
Flatulence
6%
Hyperglycaemia
6%
Leukopenia
6%
Influenza
6%
Dysuria
5%
Non-cardiac chest pain
5%
Hypothyroidism
5%
Haemoptysis
5%
Productive cough
5%
White blood cell count decreased
5%
Paraesthesia
5%
Pneumonia
3%
General physical health deterioration
2%
Pulmonary embolism
2%
Cholecystitis
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
2%
Sepsis
1%
Small intestinal obstruction
1%
Death
1%
Colitis
1%
Transient ischaemic attack
1%
Acute respiratory failure
1%
Hypercalcaemia
1%
Pancreatitis
1%
Atrial flutter
1%
Cardio-respiratory arrest
1%
Intestinal obstruction
1%
Uterine prolapse
1%
Coronary artery stenosis
1%
Blood uric acid increased
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%
Osteoarthritis
1%
Cancer pain
1%
Monoparesis
1%
Syncope
1%
Vocal cord paralysis
1%
Respiratory failure
1%
Nephrotic syndrome
1%
Acute coronary syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomization Phase: Lenvatinib 24 mg
Randomization Phase: Placebo
OOL, Treatment Period: Lenvatinib 24 mg
OOL, Treatment Period: Lenvatinib 20 mg
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 3B: Combination ExpansionExperimental Treatment3 Interventions
Participants with relapsed or refractory osteosarcoma will receive lenvatinib in combination with ifosfamide and etoposide.
Group II: Cohort 3A: Combination Dose-findingExperimental Treatment3 Interventions
Participants with relapsed or refractory osteosarcoma will receive lenvatinib in combination with ifosfamide and etoposide.
Group III: Cohort 2B: Single-agent Expansion (Osteosarcoma)Experimental Treatment1 Intervention
Participants with relapsed or refractory osteosarcoma.
Group IV: Cohort 2A: Single-agent Expansion (DTC)Experimental Treatment1 Intervention
Children and adolescents with 131 iodine-refractory DTC.
Group V: Cohort 1: Single-Agent Dose-FindingExperimental Treatment1 Intervention
Children and adolescents with relapsed or refractory solid malignant tumors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Lenvatinib
2005
Completed Phase 4
~2690
Ifosfamide
2010
Completed Phase 4
~2980
Find a Location
Who is running the clinical trial?
Eisai LimitedLead Sponsor
62 Previous Clinical Trials
14,151 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,869 Previous Clinical Trials
5,051,792 Total Patients Enrolled
5 Trials studying Osteosarcoma
1,239 Patients Enrolled for Osteosarcoma
Frequently Asked Questions
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