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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

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ClinicalTrials.gov Identifier: NCT03477175
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : July 9, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: E7080 Drug: Comparator Drug Drug: Comparator Drug: Sorafenib Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Arm Intervention/treatment
Experimental: Cohort A : Lenvatinib
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.
Drug: E7080
Oral Administration.
Other Names:
  • lenvatinib
  • lenvatinib mesilate
  • lenvatinib mesylate
  • 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate

Experimental: Cohort B: Lenvatinib plus Comparator drug
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.
Drug: E7080
Oral Administration.
Other Names:
  • lenvatinib
  • lenvatinib mesilate
  • lenvatinib mesylate
  • 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate

Drug: Comparator Drug
Per parent study.

Experimental: Cohort C: Comparator drug

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.

Drug: Comparator Drug
Per parent study.

Drug: Comparator Drug: Sorafenib
Per parent study.




Primary Outcome Measures :
  1. Number of Participants With any Serious Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months) ]
  2. Number of Participants With any TEAE [ Time Frame: Up to 28 days after the last dose of study drugs or 5*half-life of study drugs, whichever is longer (approximately 43 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477175


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_oncmedinfo@eisai.com

Locations
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Sponsors and Collaborators
Eisai Inc.
Merck Sharp & Dohme Corp.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03477175    
Other Study ID Numbers: E7080-G000-604
2017-003668-11 ( EudraCT Number )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
lenvatinib
E7080
Additional relevant MeSH terms:
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Sorafenib
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action