Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Solid Tumors lenvatinib E7080 Comparator Drug

Eligibility

You can join if…

Open to people ages 18 years and up

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)

You CAN'T join if...

  • 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

Locations

  • Harbor UCLA Medical Center
    Torrance California 90502 United States
  • Northwestern University
    Chicago Illinois 60611 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Eisai Inc.
ID
NCT03477175
Phase
Phase 2
Study Type
Interventional
Last Updated