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

An Open-label, Multi-center, Roll-over Study to Assess Long Term Safety of Lenvatinib Monotherapy or Lenvatinib Combination Regimen or Comparator Treatment Arm to Cancer Patients in Eisai Sponsored Lenvatinib Trials

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: E7080; Drug: Comparator Drug; Drug: Comparator Drug: Sorafenib

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia, 3004
    • The Alfred Hospital
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • UZ Antwerpen
  • Brussels
    • Bruxelles, Brussels, Belgium, 1200
      • Cliniques Universitaires Saint-Luc
• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University, Cancer Center
  • Guangxi
    • Guilin, Guangxi, China
      • Affiliated Hospital of Guilin Medical University
  • Heilongjiang
    • Haerbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Cancer Hospital
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China
      • No.10 People of Shanghai
  • Sichuan
    • Chengdu, Sichuan, China
      • West China School of Medicine/West China Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
• Germany
  • Essen, Germany, 45147
    • Eisai Trial Site 2
  • Würzburg, Germany, 97080
    • Eisai Trial Site 1
• Italy
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • Azienda Ospedaliero Universitaria Pisana
• Korea, Republic of
  • Seoul, Korea, Republic of, 6351
    • Samsung Medical Center - PPDS
  • Gyeonggido
    • Goyang-si, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center
• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
• Poland
  • Gliwice, Poland, 44-101
    • Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach
• Romania
  • Bucharest, Romania, 11863
    • Institutul National de Endocrinologie "C. I. Parhon"
• Thailand
  • Krung Thep Maha Nakhon
    • Pathum Wan, Krung Thep Maha Nakhon, Thailand, 10330
      • Chulalongkorn University
• United States
  • California
    • Torrance, California, United States, 90502
      • Harbor UCLA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: E7080; Oral Administration.; Other Names: lenvatinib; lenvatinib mesilate; lenvatinib mesylate; 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate
Experimental: 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.	Drug: E7080; Oral Administration.; Other Names: lenvatinib; lenvatinib mesilate; lenvatinib mesylate; 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate; Drug: Comparator Drug; Per parent study.
Experimental: 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.	Drug: Comparator Drug; Per parent study.; Drug: Comparator Drug: Sorafenib; Per parent study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with any treatment-emergent (TE) serious adverse event (SAE)	Up to 28 days after the last dose of study drugs or 5 × half-life of study drugs, whichever is longer (up to 10 years)
Number of participants with any non-serious TE adverse event (TEAE)	Up to 28 days after the last dose of study drugs or 5 × half-life of study drugs, whichever is longer (up to 10 years)
Number of Participants With any Serious Treatment-emergent Adverse Event (TEAE)	Up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months)
Number of Participants With any TEAE	Up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months)

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: lenvatinib; E7080
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Sorafenib; Lenvatinib
• Other Study ID Numbers: E7080-G000-604; 2017-003668-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No