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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477175
• Other study ID #: E7080-G000-604
• Secondary ID: 2017-003668-11
• Status: Completed
• Phase: Phase 2
• Start date: August 16, 2018
• Est. completion date: December 21, 2023

Study information

• Verified date: April 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• E7080
Oral Administration.
• Comparator Drug
Per parent study.
• Comparator Drug: Sorafenib
Per parent study.

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles	Brussels
Belgium	UZ Antwerpen	Edegem	Antwerpen
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China School of Medicine/West China Hospital, Sichuan University	Chengdu	Sichuan
China	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	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	No.10 People of Shanghai	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
Germany	Eisai trial site 2	Essen
Germany	Eisai trial site 1	Würzburg
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa	Toscana
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggido
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Netherlands	Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis	Amsterdam	Noord-Holland
Poland	Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach	Gliwice
Romania	Institutul National de Endocrinologie "C. I. Parhon"	Bucharest
Thailand	Chulalongkorn University	Pathum Wan	Krung Thep Maha Nakhon
United States	Northwestern University	Chicago	Illinois
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Harbor UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  Germany,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Romania,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)