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Tyrosine Kinase Inhibitor

Long-Term Safety of Lenvatinib for Cancer

Phase 2

Waitlist Available

Research Sponsored by Eisai Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after the last dose of study drugs or 5 × half-life of study drugs, whichever is longer (up to 10 years)

Awards & highlights

Study Summary

This trial will study the long-term safety of a drug in people who have already taken it as part of another trial.

Who is the study for?

This trial is for individuals with solid tumors who are already participating in Eisai-sponsored lenvatinib studies and benefiting from the treatment. They must be able to take oral medication, not have significant gastrointestinal issues affecting drug absorption, and agree to use effective contraception if applicable.Check my eligibility

What is being tested?

The study aims to evaluate the long-term safety of Lenvatinib alone or combined with other drugs compared to a standard treatment (Sorafenib) in patients with solid tumors. It's for those currently seeing positive results from ongoing lenvatinib trials.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any long-term safety concerns related to Lenvatinib or its combination regimens as compared to Sorafenib. These could include typical cancer treatment-related side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With any Serious Treatment-emergent Adverse Event (TEAE)

Number of Participants With any TEAE

Number of participants with any non-serious TE adverse event (TEAE)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: Comparator drugExperimental Treatment2 Interventions

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.

Group II: Cohort B: Lenvatinib plus Comparator drugExperimental Treatment2 Interventions

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.

Group III: Cohort A : LenvatinibExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

E7080

2005

Completed Phase 2

~220

Comparator Drug: Sorafenib

2018

Completed Phase 2

~40

Comparator Drug

2017

Completed Phase 2

~17610

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,110 Total Patients Enrolled

Eisai Inc.Lead Sponsor

516 Previous Clinical Trials

159,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does E7080 pose any risks to patient health and well-being?

"Our analysis has concluded that E7080 is moderately safe, and thus receives a rating of 2. This drug's safety profile is supported by clinical data from Phase 2 trials, but there are no studies demonstrating its efficacy yet."

Answered by AI

What ailments is E7080 commonly prescribed to address?

"E7080 is regularly prescribed for malignant neoplasms and potentially useful for treating a variety of other medical conditions including advanced renal cell carcinoma, metastatic radioactive iodine-refractory differentiated thyroid carcinoma, and gastrointestinal stromal tumors."

Answered by AI

Has any further research been done regarding the effects of E7080?

"According to the latest figures, there are 201 active trials researching E7080. Of those studies, 50 have reached Phase 3 status. While these experiments began in Commack, New york, clinical research is occurring at 6937 separate sites worldwide."

Answered by AI

Does this research endeavor currently accept volunteers?

"This trial is no longer open for enrollment. It had first been posted on August 16th 2018, and was last updated on May 30th 2022. Currently, there are 450 trials actively seeking patients with solid tumors and 201 studies recruiting participants to use E7080."

Answered by AI

What is the scope of individuals participating in this experiment?

"This medical trial is not accepting new participants for the time being. It was originally posted on August 16th 2018 and last updated on May 30th 2022. However, there are 450 trials recruiting people with tumors or solid cancers, as well as 201 studies seeking out those affected by E7080."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03477175.