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

NCT ID: NCT03477175

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2023-12-21

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.

Detailed Description

This is an open-label extension study to roll-over eligible participants from Eisai-sponsored lenvatinib studies. The participants may roll-over no sooner than the primary completion dates in their parent study or after all study data for the primary outcome measure have been collected for the parent study. The parent study is defined as the Eisai-sponsored lenvatinib clinical study in which the participant was receiving lenvatinib either as monotherapy or as combination therapy or was receiving any other comparator therapy. The participant can be enrolled in the current study for the purpose of long-term safety data collection if all the selection criteria for the current study are met. The intention is that the participant will not be without study drug during the transition from the parent study to the rollover study.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A : Lenvatinib

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.

Group Type: EXPERIMENTAL

E7080

Intervention Type: DRUG

Oral Administration.

Cohort B: Lenvatinib plus Comparator drug

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.

Group Type: EXPERIMENTAL

E7080

Intervention Type: DRUG

Oral Administration.

Comparator Drug

Intervention Type: DRUG

Per parent study.

Cohort C: Comparator drug

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.

Group Type: EXPERIMENTAL

Comparator Drug

Intervention Type: DRUG

Per parent study.

Comparator Drug: Sorafenib

Intervention Type: DRUG

Per parent study.

Interventions

E7080

Oral Administration.

Intervention Type: DRUG

Comparator Drug

Per parent study.

Intervention Type: DRUG

Comparator Drug: Sorafenib

Per parent study.

Intervention Type: DRUG

Other Intervention Names

lenvatinib; lenvatinib mesilate; lenvatinib mesylate; 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Harbor UCLA Medical Center

Torrance, California, United States

Northwestern University

Chicago, Illinois, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

The Alfred Hospital

Melbourne, , Australia

UZ Antwerpen

Edegem, Antwerpen, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

No.10 People of Shanghai

Shanghai, Shanghai Municipality, China

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

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Eisai trial site 2

Essen, , Germany

Eisai trial site 1

Würzburg, , Germany

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, Netherlands

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

Gliwice, , Poland

Institutul National de Endocrinologie "C. I. Parhon"

Bucharest, , Romania

National Cancer Center

Goyang-si, Gyeonggido, South Korea

Samsung Medical Center - PPDS

Seoul, , South Korea

Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Countries

United States; Australia; Belgium; China; Germany; Italy; Netherlands; Poland; Romania; South Korea; Thailand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003668-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E7080-G000-604

Identifier Type: -

Identifier Source: org_study_id