Solid TumorsPhase 2NCT03477175
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
A Phase 2 study testing E7080, Comparator Drug and Comparator Drug: Sorafenib in people with Solid Tumors, run by Eisai Inc. at 28 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- E7080, Comparator Drug and Comparator Drug: Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 28 sitesin 11 countries
- Study dates
- 16 Aug 2018to 21 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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 locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
China13 sites
The First Hospital of Jilin University
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
West China School of Medicine/West China Hospital, Sichuan University
Chengdu, Sichuan
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu
No.10 People of Shanghai
Shanghai, Shanghai Municipality
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Henan Cancer Hospital
Zhengzhou, Henan
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Karmanos Cancer Institute
Detroit, Michigan, 48201
Harbor UCLA Medical Center
Torrance, California, 90502
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
UZ Antwerpen
Edegem, Antwerpen, 2650
Germany2 sites
Eisai trial site 2
Essen, 45147
Eisai trial site 1
Würzburg, 97080
South Korea2 sites
National Cancer Center
Goyang-si, Gyeonggido, 10408
Samsung Medical Center - PPDS
Seoul, 6351
Netherlands1 site
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, North Holland, 1066 CX
Poland1 site
Centrum Onkologii Instytut im.Marii Sklodowskiej Curie-Oddzial w Gliwicach
Gliwice, 44-101
Romania1 site
Institutul National de Endocrinologie "C. I. Parhon"
Bucharest, 11863
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- E7080, Comparator Drug, Comparator Drug: Sorafenib
- Keywords
- lenvatinib, E7080
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7080Drug
Also called lenvatinib, lenvatinib mesilate, lenvatinib mesylate, 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonate
Oral Administration.
Comparator DrugDrug
Per parent study.
Comparator Drug: SorafenibDrug
Per parent study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A : Lenvatinib | Experimental | 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. Receives: Drug: E7080 |
| Cohort B: Lenvatinib plus Comparator drug | Experimental | 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. Receives: Drug: E7080; Drug: Comparator Drug |
| Cohort C: Comparator drug | Experimental | 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. Receives: Drug: Comparator Drug; Drug: Comparator Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)
A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.
Measured: Up to 58.8 months in current study
Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event.
Measured: Up to 58.8 months in current study
Number of Participants With Treatment-Related TEAEs
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE.
Measured: Up to 58.8 months in current study
Number of Participants With Any TEAE
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous.
Measured: Up to 58.8 months in current study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start16 Aug 2018
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477175
- Sponsor's protocol ID
- E7080-G000-604
- Other IDs
- 2017-003668-11, 2017
- Status last verified
- Apr 2023
- First submitted
- 20 Mar 2018
- Last updated
- 7 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03477175
- Acronym / sponsor ID
- E7080-G000-604
- Conditions
- Solid Tumors
- Keywords
- lenvatinib, E7080
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 7 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A : Lenvatinib | Experimental | Drug: E7080The 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. |
| Cohort B: Lenvatinib plus Comparator drug | Experimental | Drug: E7080, Drug: Comparator DrugThe 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. |
| Cohort C: Comparator drug | Experimental | Drug: Comparator Drug, Drug: Comparator Drug: SorafenibThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E7080Also: lenvatinib, lenvatinib mesilate, lenvatinib mesylate, 4-[3-Chloro-4-(N'-cyclopropylureido)phenoxy]-7-methoxyquinoline-6-carboxamide methanesulfonateOral Administration. | Drug | Cohort A : Lenvatinib, Cohort B: Lenvatinib plus Comparator drug |
| Comparator DrugPer parent study. | Drug | Cohort B: Lenvatinib plus Comparator drug, Cohort C: Comparator drug |
| Comparator Drug: SorafenibPer parent study. | Drug | Cohort C: Comparator drug |
Primary outcome
Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 58.8 months in current study
A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.
Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 58.8 months in current study
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event.
Number of Participants With Treatment-Related TEAEs
Time frame: Up to 58.8 months in current study
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE.
Number of Participants With Any TEAE
Time frame: Up to 58.8 months in current study
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E7080, Comparator Drug and Comparator Drug: Sorafenib in people with Solid Tumors, run by Eisai Inc. at 28 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China, United States, Belgium, Germany, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Up to 58.8 months in current study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.