Status:
COMPLETED
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
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03477175
Start Date
August 16 2018
End Date
December 21 2023
Last Update
January 7 2025
Active Locations (28)
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1
Harbor UCLA Medical Center
Torrance, California, United States, 90502
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
4
The Alfred Hospital
Melbourne, Australia, 3004