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Topoisomerase Inhibitor

Lenvatinib for Osteosarcoma

Q: For what pathologies is Lenvatinib commonly prescribed?

<p>Lenvatinib is primarily utilised to combat <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, yet it can also be prescribed as a remedy for neoplasms of the pancreas, merkel cell carcinomas and progressive radiation-resistant <a href="https://www.withpower.com/clinical-trials/thyroid">thyroid</a> malignancies.</p>

Phase 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 the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first (up to 14.2 months)

Awards & highlights

Study Summary

This trial is testing a new cancer drug combination in children, adolescents, and young adults with osteosarcoma that has come back or does not respond to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first (up to 14.2 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first (up to 14.2 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of the first documentation of pd or date of death, whichever occurred first (up to 14.2 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

Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment

Secondary outcome measures

Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4

Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4

Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib

+8 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%

Thrombocytopenia

10%

Oral pain

10%

Blood creatinine increased

10%

Electrocardiogram QT prolonged

10%

Hypoalbuminaemia

10%

Upper respiratory tract infection

Dehydration

Neck pain

Hypomagnesaemia

Influenza like illness

Muscle spasms

Depression

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Hyponatraemia

Ejection fraction decreased

Haematuria

Malaise

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Pruritus

Influenza

Anxiety

Flatulence

Hyperglycaemia

Leukopenia

Dysuria

Paraesthesia

Non-cardiac chest pain

Productive cough

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Sepsis

Cholecystitis

Pulmonary embolism

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Malignant pleural effusion

Spinal cord compression

Acute kidney injury

Acute coronary syndrome

Blood uric acid increased

Death

Monoparesis

Small intestinal obstruction

Hypercalcaemia

Intestinal obstruction

Osteoarthritis

Colitis

Transient ischaemic attack

Acute respiratory failure

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Hepatic failure

Liver injury

Diverticulitis

Appendicitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Intracranial tumour haemorrhage

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Respiratory failure

Nephrotic syndrome

100%

80%

60%

40%

20%

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

2Treatment groups

Experimental Treatment

Active Control

Group I: Randomization Phase: Lenvatinib + Ifosfamide + EtoposideExperimental Treatment3 Interventions

Participants with relapsed or refractory osteosarcoma will receive lenvatinib in combination with ifosfamide and etoposide.

Group II: Randomization Phase: Ifosfamide + EtoposideActive Control3 Interventions

Participants with relapsed or refractory osteosarcoma will receive ifosfamide with etoposide. Participants with relapsed or refractory osteosarcoma may receive optional lenvatinib plus or minus chemotherapy (Ifosfamide and Etoposide) if disease progression is observed in study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

2010

Completed Phase 4

~2980

Lenvatinib

2005

Completed Phase 4

~2690

Etoposide

2010

Completed Phase 3

~2440

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eisai Inc.Lead Sponsor

515 Previous Clinical Trials

153,939 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,490 Total Patients Enrolled

5 Trials studying Osteosarcoma

1,275 Patients Enrolled for Osteosarcoma

Media Library

Etoposide (Topoisomerase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04154189 — Phase 2

Osteosarcoma Research Study Groups: Randomization Phase: Lenvatinib + Ifosfamide + Etoposide, Randomization Phase: Ifosfamide + Etoposide

Osteosarcoma Clinical Trial 2023: Etoposide Highlights & Side Effects. Trial Name: NCT04154189 — Phase 2

Etoposide (Topoisomerase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04154189 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this examination available at the present time?

"This particular trial, posted in March 2020 and last updated on November 8th 2022, is not presently enrolling study participants. However; there are currently 591 other studies actively recruiting patients."

Answered by AI

What is the total patient count for this clinical experiment?

"Sadly, this trial has completed recruiting. It was first posted on March 23rd 2020 and the latest update came out of November 8th 2022. If you are searching for other trials, 112 studies are accepting patients with osteosarcoma, while 479 different clinicals have openings for Lenvatinib-based treatments."

Answered by AI

Is Lenvatinib considered a safe and reliable treatment option?

"Given the fact this is a Phase 2 trial, which has some evidence for safety but none for efficacy, Lenvatinib was rated with a score of 2 on our team's scale."

Answered by AI

For what pathologies is Lenvatinib commonly prescribed?

"Lenvatinib is primarily utilised to combat bladder cancer, yet it can also be prescribed as a remedy for neoplasms of the pancreas, merkel cell carcinomas and progressive radiation-resistant thyroid malignancies."

Answered by AI

Are there any other studies that have investigated the benefits of Lenvatinib?

"At present, Lenvatinib is featured in 479 active clinical trials with 129 of those studies currently in Phase 3. In the USA, there are 21563 different sites where these trials take place, though New york City has an outsized presence."

Answered by AI

What criteria must individuals meet to be eligible for this research?

"This study is enrolling 72 people with osteosarcoma between the ages of 2 and 25. In order to participate, patients must meet a variety of criteria such as having blood pressure under 95th percentile according to National Heart Lung and Blood Institute guidelines, no prior use of lenvatinib, measurable or evaluable disease per RECIST 1.1., life expectancy exceeding 12 weeks, any relevant washouts (3-6 weeks depending on treatment), recovery from acute toxic effects of all prior anti-cancer therapy before Cycle 1 Day 1, refractory/relapsed status after one to two previous lines of systemic treatments alongside either"

Answered by AI

Are there a plethora of sites operating this trial in the city?

"Patients may enroll in this trial at Childrens Hospital Colorado, located in Aurora, Colorado; the Hospital For Sick Children situated in Toronto, Alabama; and Children's of Alabama based in Birmingham, California. In addition to these sites there are 17 other medical locations that accept patients for this study."

Answered by AI

Does the study embrace participants aged 45 and over?

"According to the inclusion criteria, this study is open only to individuals between two and twenty-five years of age. More broadly, there are 244 clinical trials targeting children under 18, as well as 406 specifically tailored for those over 65."

Answered by AI

Recent research and studies

Future OncologyJournal

OLIE, ITCC-082: A Phase II Trial of Lenvatinib Plus Ifosfamide and Etoposide in Relapsed/refractory Osteosarcoma

Gaspar, Nathalie, Quentin Campbell-Hewson, Jie Huang, Chinyere E Okpara, and Francisco Bautista. 2021. “OLIE, ITCC-082: A Phase II Trial of Lenvatinib Plus Ifosfamide and Etoposide in Relapsed/refractory Osteosarcoma”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-0743.

The Lancet OncologyJournal

Lenvatinib with Etoposide Plus Ifosfamide in Patients with Refractory or Relapsed Osteosarcoma (ITCC-050): A Multicentre, Open-label, Multicohort, Phase 1/2 Study

Gaspar, Nathalie, Rajkumar Venkatramani, Stefanie Hecker-Nolting, Soledad Gallego Melcon, Franco Locatelli, Francisco Bautista, Alessandra Longhi, et al.. 2021. “Lenvatinib with Etoposide Plus Ifosfamide in Patients with Refractory or Relapsed Osteosarcoma (ITCC-050): A Multicentre, Open-label, Multicohort, Phase 1/2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00387-9.

Future OncologyJournal

OLIE, ITCC-082: A Phase II Trial of Lenvatinib Plus Ifosfamide and Etoposide in Relapsed/refractory Osteosarcoma

clinicaltrials.govStudy

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma