Hypervascular Tumor and Arteriovenous MalformationPhase 3NCT01677624
A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
A Phase 3 study testing E7040 in people with Hypervascular Tumor and Arteriovenous Malformation, run by Eisai Co., Ltd. at 10 sites in Japan.
Trial summary
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypervascular Tumor and Arteriovenous Malformation
- What is being tested?
- E7040
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 10 sitesJapan
- Study dates
- Aug 2012to Mar 2014
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects who are subject to any of the following vascular embolization therapies
- Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumor confirmed by dynamic computerized tomography (CT) after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor, and are not amenable to resection and local therapy, and meet any of the following (a) to (c).
- 1 lesion of >50 mm in diameter
- 2 or 3 lesions of >30 mm in at least one diameter
- 4 or more lesions
- Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deep stained early stage tumor confirmed by dynamic CT after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor but not amenable to resection, and whose primary lesion and extrahepatic lesion are controlled.
Show all 14Show fewer
- Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stained early stage tumor confirmed by dynamic CT after bolus injection of contrast media and who have a typical finding of hypervascular tumor other than the liver (e.g., renal cell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b).
- Subjects applicable to pre-operative arterial embolization therapy to reduce tumor size or volume of bleeding for safer conduct of surgical resection or local therapy (e.g., radiofrequency ablation (RFA))
- Subjects in stable general condition and are applicable to pain control treatment
- Arteriovenous malformation:
- Subjects with arteriovenous malformation (except for central nervous system, heart, and lung) confirmed by dynamic CT but at a low risk of undesirable reflux into systemic circulation and with vessel malformation suitable for particle embolization in size
- 2. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (PS 0-1 for metastatic hepatic cancer)
- 3. No carry-over effect of prior therapy or adverse drug reactions which may influence the embolic effect of E7040, if having a history of prior therapy time elapsed from the end of prior therapy to the start of E7040 embolization therapy should be: Surgery: greater than or equal to 6 weeks Local therapy: greater than or equal to 4 weeks Embolization for non-target vessel: greater than or equal to 4 weeks
- 4. With a survival of greater than or equal to 12 months after the prior arterial embolization therapy using E7040
Who cannot join
- Subjects with clinical symptom or brain metastasis or cerebral encephalopathy requiring medical treatment
- Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in patients with any disease other than HCC
- Previously treated with arterial embolization therapy in target vessel
- Previously treated with arterial embolization therapy in non-target vessel, resection in target organ, or local therapy (e.g., RFA) (except for HCC patient)
- Subjects expected to have artery-pulmonary vein shunt or right-to-left shunt, or those with a possible risk of influx of embolized particles into the central nervous system.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Chikushino-shi, Fukuoka
Study site
Chuo-ku, Tokyo
Study site
Hirosaki, Aomori
Study site
Kagoshima, Kagoshima-ken
Study site
Kanazawa, Ishikawa-ken
Study site
Kurume, Fukuoka
Study site
Minato-ku, Tokyo
Study site
Nishinomiya, Hyōgo
Study site
Okayama, Okayama-ken
Study site
Tsu, Mie-ken
About this study
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
- Being tested
- E7040
- Keywords
- Hypervascular tumor, arteriovenous malformation, arterial embolization
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7040Device
E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
| Study group | Role | What they receive |
|---|---|---|
| E7040 | Experimental | Not described Receives: Device: E7040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Embolization in the Target Vessel
Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.
Measured: Day 1 (embolization) up to Day 30 after treatment
Secondary outcomes (1)
Success Rate for Operability of Embolization
Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.
Measured: Day 1 (embolization) up to Day 30 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionMar 2014
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 Hypervascular Tumor and Arteriovenous MalformationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shin Maeda, Study director, Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677624
- Sponsor's protocol ID
- E7040-J081-301
- Status last verified
- Jan 2016
- First submitted
- 30 Aug 2012
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
- ClinicalTrials.gov ID
- NCT01677624
- Acronym / sponsor ID
- E7040-J081-301
- Keywords
- Hypervascular tumor, arteriovenous malformation, arterial embolization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Posted 22 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E7040 | Experimental | Device: E7040 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Subjects who are subject to any of the following vascular embolization therapies
- Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumor confirmed by dynamic computerized tomography (CT) after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor, and are not amenable to resection and local therapy, and meet any of the following (a) to (c).
- Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deep stained early stage tumor confirmed by dynamic CT after bolus intravenous infusion of contrast media and have a typical finding of hypervascular tumor but not amenable to resection, and whose primary lesion and extrahepatic lesion are controlled.
- Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stained early stage tumor confirmed by dynamic CT after bolus injection of contrast media and who have a typical finding of hypervascular tumor other than the liver (e.g., renal cell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b).
- Arteriovenous malformation:
Key exclusion criteria (5 listed)
- Subjects with clinical symptom or brain metastasis or cerebral encephalopathy requiring medical treatment
- Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in patients with any disease other than HCC
- Previously treated with arterial embolization therapy in target vessel
- Previously treated with arterial embolization therapy in non-target vessel, resection in target organ, or local therapy (e.g., RFA) (except for HCC patient)
- Subjects expected to have artery-pulmonary vein shunt or right-to-left shunt, or those with a possible risk of influx of embolized particles into the central nervous system.
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 |
|---|---|---|
| E7040E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered . | Device | E7040 |
Primary outcome
Success Rate of Embolization in the Target Vessel
Time frame: Day 1 (embolization) up to Day 30 after treatment
Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.
1 secondary outcome
Success Rate for Operability of Embolization
Time frame: Day 1 (embolization) up to Day 30 after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Shin Maeda study director
Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing E7040 in people with Hypervascular Tumor and Arteriovenous Malformation, run by Eisai Co., Ltd. at 10 sites 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 14 inclusion and 5 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Feb 2016). 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?
Success Rate of Embolization in the Target Vessel (time frame: Day 1 (embolization) up to Day 30 after treatment). 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 Feb 2016.