NCT03477175

Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials

Completed Phase 2 Results posted Last updated 7 January 2025

What this trial tests

Phase 2 trial testing E7080 in Solid Tumors in 40 participants. Completed in 21 December 2023.

Timeline

16 August 2018

Primary endpoint
21 December 2023

21 December 2023

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	16 August 2018
Primary completion	21 December 2023
Estimated completion	21 December 2023
Sites	28 locations across Italy, Netherlands, Belgium, Germany, Poland, South Korea, Romania, Thailand

Drugs / interventions tested

• E7080
• Comparator Drug
• Comparator Drug: Sorafenib — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Eisai Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs) Primary · Up to 58.8 months in current study

A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose

Group	Value	95% CI
Cohort A, China: Lenvatinib Monotherapy	7
Cohort A, Rest of the World: Lenvatinib Monotherapy	14

Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs) Primary · Up to 58.8 months in current study

A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event.

Group	Value	95% CI
Cohort A, China: Lenvatinib Monotherapy	18
Cohort A, Rest of the World: Lenvatinib Monotherapy	17

Number of Participants With Treatment-Related TEAEs Primary · Up to 58.8 months in current study

A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE.

Group	Value	95% CI
Cohort A, China: Lenvatinib Monotherapy	15
Cohort A, Rest of the World: Lenvatinib Monotherapy	14

Number of Participants With Any TEAE Primary · Up to 58.8 months in current study

A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous.

Group	Value	95% CI
Cohort A, China: Lenvatinib Monotherapy	18
Cohort A, Rest of the World: Lenvatinib Monotherapy	20

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 58.8 months in current study. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A, China: Lenvatinib Monotherapy

Serious: 7/19 (37%)

Deaths: 2/19

Cohort A, Rest of the World: Lenvatinib Monotherapy

Serious: 14/21 (67%)

Deaths: 5/21

Serious adverse events (34 terms)

Reaction	System	Cohort A, China: Lenvatini…	Cohort A, Rest of the Worl…
Pneumonia	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Haemorrhoidal haemorrhage	Gastrointestinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Large intestine polyp	Gastrointestinal disorders	—	—
COVID-19	Infections and infestations	—	—
Pulmonary sepsis	Infections and infestations	—	—
Post procedural haematoma	Injury, poisoning and procedural complications	—	—
Spinal compression fracture	Injury, poisoning and procedural complications	—	—
Hypovolaemia	Metabolism and nutrition disorders	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Dizziness	Nervous system disorders	—	—
Hypoaesthesia	Nervous system disorders	—	—
Seizure	Nervous system disorders	—	—
Haematuria	Renal and urinary disorders	—	—

Other adverse events (79 terms — click to expand)

Reaction	System	Cohort A, China: Lenvatini…	Cohort A, Rest of the Worl…
Proteinuria	Renal and urinary disorders	—	—
Weight decreased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
COVID-19	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Albuminuria	Renal and urinary disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Haematuria	Renal and urinary disorders	—	—
Fatigue	General disorders	—	—
Bronchitis	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Gamma-glutamyltransferase increased	Investigations	—	—
Urinary occult blood positive	Investigations	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—
Periarthritis	Musculoskeletal and connective tissue disorders	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Varicose vein	Vascular disorders	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Aphthous ulcer	Gastrointestinal disorders	—	—
Gingival disorder	Gastrointestinal disorders	—	—
Gingival pain	Gastrointestinal disorders	—	—
Haemorrhoids	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Peripheral swelling	General disorders	—	—
Pyrexia	General disorders	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—

Most-reported serious reactions: Pneumonia, Urinary tract infection, Acute myocardial infarction, Angina pectoris, Cardiac failure, Myocardial infarction, Abdominal pain, Diarrhoea.

Data from ClinicalTrials.gov NCT03477175 adverse events section.

Sponsor's own description

This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.