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

Eisai

Status and phase: Completed; Phase 2

Conditions: Solid Tumors

Treatments: Drug: E7080; Drug: Comparator Drug: Sorafenib; Drug: Comparator Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT03477175

E7080-G000-604

2017-003668-11 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

Cohort A : Lenvatinib

Experimental group

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.

Treatment:

Drug: E7080

Cohort B: Lenvatinib plus Comparator drug

Experimental group

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.

Treatment:

Drug: Comparator Drug

Drug: E7080

Cohort C: Comparator drug

Experimental group

Description:

The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive comparator treatment, with exception of participants receiving placebo. For China only: The roll-over eligible participants from Eisai-sponsored lenvatinib studies who received comparator treatment in their parent study will continue to receive sorafenib, with exception of participants receiving placebo.

Treatment:

Drug: Comparator Drug

Drug: Comparator Drug: Sorafenib