Refractory Solid TumorsPhase 1NCT01525394
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
A Phase 1 study testing Lenvatinib and Moxifloxacin 400 mg in people with Refractory Solid Tumors and Lymphomas, run by Eisai Inc. at 1 site in United States.
Trial summary
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Solid Tumors, Lymphomas
- What is being tested?
- Lenvatinib and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in this study:
- Normal, healthy male and female subjects greater than or equal to 18 years of age at the time of informed consent.
- All females must have a negative serum human chorionic gonadotropin (hCG) pregnancy test result at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device (IUD), a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as greater than age 50 and at least 12 months of amenorrhea) or subjects who have been sterilized surgically or who are otherwise proven sterile (e.g., bilateral tubal ligation with surgery at least 6 months prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 2 months prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- Male patients who are not abstinent or have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly affective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
- Partners of male and female subjects must use an effective method of contraception (e.g., barrier method, IUD), commencing prior to or at initiation of study drug and continuing for the duration of the study and for 30 days after study drug discontinuation. All females who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- Voluntarily provide written informed consent prior to any study procedures.
- Are willing and able to comply with all aspects of the protocol for the duration of the study.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Subjects with any clinically significant abnormality, including a QTc interval of greater than 450 msec, on 12-lead ECG at the time of the Screening Period, Baseline Periods, or 30 minutes before administration of study drug.
- A history of myocardial infarction, syncope or cardiac arrhythmias.
- A history of uncontrolled hypertension, defined as a systolic pressure of greater than 140 mm Hg and diastolic pressure of greater than 90 mm Hg.
- A history of unstable heart disease or additional risk factors for Torsades de Pointes (TdP) including heart failure, hypokalemia, or a family history of congenital long QT syndrome or unexplained cardiac arrest.
- Subjects with a history of gastrointestinal surgery (hepatectomy, nephrotomy, digestive organ resection, etc.) that may affect PK profiles of lenvatinib.
Show all 14Show fewer
- Known intolerance to the study drug or moxifloxacin (Avelox) (or any of the excipients).
- A positive result from human immunodeficiency virus (HIV), hepatitis A antibody (HAVAb), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) tests at Screening.
- A known or suspected history of drug or alcohol misuse within 6 months prior to Screening, or who have a positive urine drug test or breath alcohol test at Screening.
- Subjects who participated in another clinical trial of an investigational drug or device within 4 weeks prior to dosing.
- Subjects who received blood products within 4 weeks, or donated blood within 8 weeks, or donated plasma within one week of dosing.
- Subjects who have engaged in heavy exercise within 2 weeks prior to check-in (e.g., marathon runners, weight lifters, etc.).
- Females who are pregnant or breastfeeding.
- Subjects who are unwilling or unable to abide by the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.
- Conditions
- Refractory Solid Tumors, Lymphomas
- Being tested
- Lenvatinib, Moxifloxacin 400 mg, Placebos (matched to 4 mg and 10 mg lenvatinib capsules).
- Keywords
- lymphomas, Refractory solid tumors
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called E7080
32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose.
Moxifloxacin 400 mgDrug
Moxifloxacin 400 mg will be administered orally as one 400 mg tablet.
Placebos (matched to 4 mg and 10 mg lenvatinib capsules).Drug
The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib Capsules | Experimental | Not described Receives: Drug: Lenvatinib |
| Moxifloxacin tablets | Active comparator | Not described Receives: Drug: Moxifloxacin 400 mg |
| Placebos | Placebo comparator | Not described Receives: Drug: Placebos (matched to 4 mg and 10 mg lenvatinib capsules). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control.
Measured: 2 months
Secondary outcomes (1)
To evaluate the safety of lenvatinib in healthy subjects.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Shumaker, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525394
- Sponsor's protocol ID
- E7080-A001-002
- Status last verified
- Apr 2012
- First submitted
- 31 Jan 2012
- Last updated
- 22 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
- ClinicalTrials.gov ID
- NCT01525394
- Acronym / sponsor ID
- E7080-A001-002
- Conditions
- Refractory Solid Tumors, Lymphomas
- Keywords
- lymphomas, Refractory solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization. The Pre-Randomization Phase consists of Screening and Baseline Period 1. The Randomization Phase consists of five periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, and Treatment Period 3. Completion of study termination procedures will be performed at Visit 11.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib Capsules | Experimental | Drug: Lenvatinib |
| Moxifloxacin tablets | Active comparator | Drug: Moxifloxacin 400 mg |
| Placebos | Placebo comparator | Drug: Placebos (matched to 4 mg and 10 mg lenvatinib capsules). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal, healthy male and female subjects greater than or equal to 18 years of age at the time of informed consent.
- All females must have a negative serum human chorionic gonadotropin (hCG) pregnancy test result at Screening and Baseline. Females of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device (IUD), a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner) throughout the entire study period and for 30 days after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as greater than age 50 and at least 12 months of amenorrhea) or subjects who have been sterilized surgically or who are otherwise proven sterile (e.g., bilateral tubal ligation with surgery at least 6 months prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 2 months prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- Male patients who are not abstinent or have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly affective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
- Partners of male and female subjects must use an effective method of contraception (e.g., barrier method, IUD), commencing prior to or at initiation of study drug and continuing for the duration of the study and for 30 days after study drug discontinuation. All females who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- Voluntarily provide written informed consent prior to any study procedures.
Key exclusion criteria (14 listed)
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Subjects with any clinically significant abnormality, including a QTc interval of greater than 450 msec, on 12-lead ECG at the time of the Screening Period, Baseline Periods, or 30 minutes before administration of study drug.
- A history of myocardial infarction, syncope or cardiac arrhythmias.
- A history of uncontrolled hypertension, defined as a systolic pressure of greater than 140 mm Hg and diastolic pressure of greater than 90 mm Hg.
- A history of unstable heart disease or additional risk factors for Torsades de Pointes (TdP) including heart failure, hypokalemia, or a family history of congenital long QT syndrome or unexplained cardiac arrest.
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 |
|---|---|---|
| LenvatinibAlso: E708032 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose. | Drug | Lenvatinib Capsules |
| Moxifloxacin 400 mgMoxifloxacin 400 mg will be administered orally as one 400 mg tablet. | Drug | Moxifloxacin tablets |
| Placebos (matched to 4 mg and 10 mg lenvatinib capsules).The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules. | Drug | Placebos |
Primary outcome
To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control.
Time frame: 2 months
1 secondary outcome
To evaluate the safety of lenvatinib in healthy subjects.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
Robert Shumaker study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenvatinib and Moxifloxacin 400 mg in people with Refractory Solid Tumors and Lymphomas, run by Eisai Inc. at 1 site in United States.
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 7 inclusion and 14 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control. (time frame: 2 months). 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 22 Jun 2023.