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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03477175




Registration number
NCT03477175
Ethics application status
Date submitted
20/03/2018
Date registered
26/03/2018
Date last updated
28/02/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2017-003668-11
Secondary ID [2] 0 0
E7080-G000-604
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E7080
Treatment: Drugs - Comparator Drug
Treatment: Drugs - Comparator Drug: Sorafenib

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.

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.

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.


Treatment: Drugs: E7080
Oral Administration.

Treatment: Drugs: Comparator Drug
Per parent study.

Treatment: Drugs: Comparator Drug: Sorafenib
Per parent study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with any treatment-emergent (TE) serious adverse event (SAE)
Timepoint [1] 0 0
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 outcome [2] 0 0
Number of participants with any non-serious TE adverse event (TEAE)
Timepoint [2] 0 0
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 outcome [3] 0 0
Number of Participants With any Serious Treatment-emergent Adverse Event (TEAE)
Timepoint [3] 0 0
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 outcome [4] 0 0
Number of Participants With any TEAE
Timepoint [4] 0 0
Up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2023
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerpen
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
China
State/province [7] 0 0
Guangxi
Country [8] 0 0
China
State/province [8] 0 0
Heilongjiang
Country [9] 0 0
China
State/province [9] 0 0
Henan
Country [10] 0 0
China
State/province [10] 0 0
Hubei
Country [11] 0 0
China
State/province [11] 0 0
Hunan
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jilin
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Sichuan
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Würzburg
Country [20] 0 0
Italy
State/province [20] 0 0
Toscana
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Gyeonggido
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Netherlands
State/province [23] 0 0
Noord-Holland
Country [24] 0 0
Poland
State/province [24] 0 0
Gliwice
Country [25] 0 0
Romania
State/province [25] 0 0
Bucharest
Country [26] 0 0
Thailand
State/province [26] 0 0
Krung Thep Maha Nakhon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03477175
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03477175