Clinical trial · Interventional
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
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
NCT03477175CI-TRIAL-00084386completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator Drug | Drug | — | UNRESOLVED |
| Comparator Drug: Sorafenib | Drug | — | UNRESOLVED |
| E7080 | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A : Lenvatinib
- description
- 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.
- interventionNames
- Drug: E7080
- type
- EXPERIMENTAL
- label
- Cohort B: Lenvatinib plus Comparator drug
- description
- 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.
- interventionNames
- Drug: E7080
- Drug: Comparator Drug
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.