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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    50
  • sponsor
    Eisai Inc.
Updated on 15 July 2021
Investigator
Eisai Medical Information
Primary Contact
Karmanos Cancer Institute (2.5 mi away) Contact
+38 other location

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.

Details
Condition Solid Tumors, Solid Neoplasm, Solid Tumour
Treatment E7080, Comparator Drug, Comparator Drug: Sorafenib
Clinical Study IdentifierNCT03477175
SponsorEisai Inc.
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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