CancerPhase 1NCT01268293

A Study of E7080 in Subjects With Solid Tumor

A Phase 1 study testing E7080 in people with Cancer, run by Eisai Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cancer
What is being tested?: E7080
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteJapan
Study dates: Feb 2011to Apr 2013
Phase: Phase 1
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with histologically and/or cytologically diagnosis of solid tumor
Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
Subjects who completed previous anti-tumor therapy before at least 4 weeks
Subjects who are 20 years or older
Subjects with 0 to 1 of Performance Status

Show all 10Show fewer

Subjects agree to be hospitalized for DLT observation
Subjects with adequate organ functions
Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
Agree to participate in this study in writing based on voluntary will

Who cannot join

Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
Subjects with the severe complication or disease history
Subjects unable to take oral medication.
Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
Scheduled for surgery during the projected course of the study.
Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.

Show all 9Show fewer

Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
Pregnant or nursing subjects
Subjects who are participating in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Chuo-ku, Tokyo

Other trials in Japan

About this study

Official title: A Phase 1 Study of E7080 in Subjects With Solid Tumor

Conditions: Cancer
Being tested: E7080
Keywords: Cancer
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E7080Drug
This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

Study groups in NCT01268293
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: E7080

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicity (DLT)
Measured: Up to 4 weeks
Number of Participants With Adverse Events
Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).
Measured: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Apr 2013

First posted30 Dec 2010 (estimated)
Study startFeb 2011
Primary completionDec 2011
Study completionApr 2013

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 CancerStudies of the same condition, open and under way.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01268293
Sponsor's protocol ID: E7080-J081-105
Status last verified: Aug 2016
First submitted: 28 Dec 2010
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma

All Cancer trials

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 Phase 1 Study of E7080 in Subjects With Solid Tumor
ClinicalTrials.gov ID: NCT01268293
Acronym / sponsor ID: E7080-J081-105
Conditions: Cancer
Keywords: Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Dec 2011 (actual)
Study completion: Apr 2013 (actual)
First posted: 30 Dec 2010 (estimated)
Results: Posted 6 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: E7080

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects with histologically and/or cytologically diagnosis of solid tumor
Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
Subjects who completed previous anti-tumor therapy before at least 4 weeks
Subjects who are 20 years or older

Key exclusion criteria (9 listed)

Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
Subjects with the severe complication or disease history
Subjects unable to take oral medication.
Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
Scheduled for surgery during the projected course of the study.

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
E7080This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.	Drug	1

Primary outcome

Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 4 weeks
Number of Participants With Adverse Events
Time frame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).

Results and safety

Results posted to the registry on 6 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
E7080	9	0

Primary outcome: Number of Participants With Dose Limiting Toxicity (DLT)

Time frame: Up to 4 weeks. Number. Unit: Participants

Measure	E7080 n = 9
Value	0

Population analysed: Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.

Primary outcome: Number of Participants With Adverse Events

Time frame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).. Number. Unit: Participants

Measure	E7080 n = 9
Value	9

Population analysed: The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
E7080	1 of 9 (11.1%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cancer

Not yet recruitingPhase 3
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP), Juvenile-onset Recurrent Respiratory Papillomatosis
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma

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.

Tatsuya Sasaki study director

Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.

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 E7080 in people with Cancer, run by Eisai Co., Ltd. at 1 site in Japan.

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 10 inclusion and 9 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 Japan. 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 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?

Yes. Results are posted in the registry (first posted 6 Mar 2015). 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 Dose Limiting Toxicity (DLT) (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01268293.

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.