Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors
Keywords: lenvatinib
E7080
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to 58.8 months in current study
measure: Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 58.8 months in current study
measure: Number of Participants With Treatment-Related TEAEs
timeFrame: Up to 58.8 months in current study
measure: Number of Participants With Any TEAE
timeFrame: Up to 58.8 months in current study
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Haerbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: No.10 People of Shanghai
state: Shanghai
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Essen
country: Germany
facility: Eisai trial site 2
city: Würzburg
country: Germany
facility: Eisai trial site 1
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: Toscana
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
state: Noord-Holland
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach
city: Bucharest
country: Romania
facility: Institutul National de Endocrinologie "C. I. Parhon"
city: Pathum Wan
country: Thailand
facility: Chulalongkorn University
state: Krung Thep Maha Nakhon
Study officials:
References: