Thyroid cancer
Conditions
Interventions
Subjects enrolled from parent study will enter the roll-over study and will
continue the study drug of lenvatinib, or combination regimen, or any other
comparator therapy at the same doses upon disc
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Currently enrolled in an Eisai sponsored lenvatinib clinical study and still receiving at least one of the study drugs from that protocol 2. Currently deriving clinical benefit from at least one of the study drug(s) as determined by the investigator 3. Must be able and willing to comply with the current roll-over protocol requirements 4. Continued ability to swallow and retain orally administered study drug(s) 5. Does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels 6. Women of childbearing potential 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 7. 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
Exclusion criteria: 1. Permanent discontinuation of all study drug(s) in the parent study due to toxicity or disease progression and without clinical benefit 2. Receiving any prohibited medication(s) as described in the parent study 3. 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 4. Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to the roll-over study that may interfere with assessment of toxicity 5. Pregnant or lactating female 6. 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 subject's safety in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Safety Analysis Set is the group of subjects who received at least 1 dose of study drug(s). The Safety Analysis Set will be used in all analyses of safety. The following safety tables and listings will be available for review: * Extent of exposure, TEAEs, SAEs, TEAEs/SAEs related to study drug(s), TEAEs leading to discontinuation of study drug(s)/withdrawal, fatal TEAEs and deaths. * Other TEAEs that the investigator deemed important to report and reasons for discontinuation of study drug(s). | — |
Countries
Netherlands
Outcome results
None listed