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

NCT03477175 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: E7080-G000-6042017-003668-11
• Study Type: interventional
• Target: 40
• Locations: 11 countries
• Sites: 28

Brief Summary

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.

Conditions

Solid Tumors

Keywords

lenvatinib; E7080

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)

  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: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.

  Up to 58.8 months in current study

• Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs)

  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.

  Up to 58.8 months in current study

• Number of Participants With Treatment-Related TEAEs

  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.

  Up to 58.8 months in current study

• Number of Participants With Any TEAE

  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.

  Up to 58.8 months in current study

Study Arms (3)

Cohort A : Lenvatinib

EXPERIMENTAL

The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study will continue to receive lenvatinib monotherapy.

Drug: E7080

Cohort B: Lenvatinib plus Comparator drug

EXPERIMENTAL

The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received lenvatinib combination therapy or who crossed over from a comparator arm to receive lenvatinib combination therapy in their parent study will continue to receive lenvatinib combination therapy.

Drug: E7080; Drug: Comparator Drug

Cohort C: Comparator drug

EXPERIMENTAL

The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive comparator treatment, with exception of participants receiving placebo. For China only: The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive sorafenib, with exception of participants receiving placebo.

Drug: Comparator Drug; Drug: Comparator Drug: Sorafenib

Interventions

E7080 DRUG

Oral Administration.

Also known as: lenvatinib, lenvatinib mesilate, lenvatinib mesylate, 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate

Cohort A : Lenvatinib; Cohort B: Lenvatinib plus Comparator drug

Comparator Drug DRUG

Per parent study.

Cohort B: Lenvatinib plus Comparator drug; Cohort C: Comparator drug

Comparator Drug: Sorafenib DRUG

Per parent study.

Cohort C: Comparator drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• It is required for all participants currently participating in other lenvatinib studies to meet the following eligibility criteria.
• Provide signed written informed consent for the roll-over study
• Currently enrolled in an Eisai-sponsored lenvatinib clinical study and still receiving at least one of the study drugs from that protocol
• Currently deriving clinical benefit from at least one of the study drug(s) as determined by the investigator
• Must be able and willing to comply with the current roll-over protocol requirements
• Continued ability to swallow and retain orally administered study drug(s)
• Does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
• Women of childbearing potential and men with reproductive potential (if specified by the parent study) must be willing to continue to use highly effective methods of contraception as per local practices of standard of care during the period of the study
• Women of childbearing potential must have a negative serum pregnancy test at the time of transition to the study and before continuing study drug(s)

You may not qualify if:

• Permanent discontinuation of all study drug(s) in the parent study due to toxicity or disease progression and without clinical benefit
• Receiving any prohibited medication(s) as described in the parent study
• Any unresolved toxicity that meets the criteria for study drug(s) discontinuation or withdrawal criteria from the parent study at the time of transition to this study
• Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to the roll-over study that may interfere with assessment of toxicity
• Pregnant or lactating female
• Any serious and/or unstable pre-existing medical condition, psychiatric disorder or other conditions at the time of transition to the roll-over study that could interfere with participant's safety in the opinion of the investigator

Sponsors & Collaborators

• Eisai Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (28)

Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

UZ Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

No.10 People of Shanghai

Shanghai, Shanghai Municipality, China

Location

West China School of Medicine/West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Eisai trial site 2

Essen, 45147, Germany

Location

Eisai trial site 1

Würzburg, 97080, Germany

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56124, Italy

Location

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach

Gliwice, 44-101, Poland

Location

Institutul National de Endocrinologie "C. I. Parhon"

Bucharest, 11863, Romania

Location

National Cancer Center

Goyang-si, Gyeonggido, 10408, South Korea

Location

Samsung Medical Center - PPDS

Seoul, 6351, South Korea

Location

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Interventions

lenvatinib

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 26, 2018
• Study Start: August 16, 2018
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2023-04

Locations

US (3); BE (2); CN (13); AU (1); IT (1); PL (1); KR (2); TH (1); NL (1); DE (2); RO (1)