A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

NCT ID: NCT01677624

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-03-31

Brief Summary

To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in Japanese subjects with hypervascular tumor or arteriovenous malformation

Conditions

Hypervascular Tumor and Arteriovenous Malformation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E7040

Group Type: EXPERIMENTAL

E7040

Intervention Type: DEVICE

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 .

Interventions

E7040

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 .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects who are subject to any of the following vascular embolization therapies

1. 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. 1 lesion of >50 mm in diameter

2. 2 or 3 lesions of >30 mm in at least one diameter

3. 4 or more lesions

2. 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.

3. 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).

1. 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))

2. Subjects in stable general condition and are applicable to pain control treatment

4. 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

Exclusion Criteria

1. Subjects with clinical symptom or brain metastasis or cerebral encephalopathy requiring medical treatment

2. Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in patients with any disease other than HCC

3. Previously treated with arterial embolization therapy in target vessel

4. Previously treated with arterial embolization therapy in non-target vessel, resection in target organ, or local therapy (e.g., RFA) (except for HCC patient)

5. 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shin Maeda

Role: STUDY_DIRECTOR

Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems

Locations

Hirosaki, Aomori, Japan

Chikushino-shi, Fukuoka, Japan

Kurume, Fukuoka, Japan

Nishinomiya, Hyōgo, Japan

Kanazawa, Ishikawa-ken, Japan

Kagoshima, Kagoshima-ken, Japan

Tsu, Mie-ken, Japan

Okayama, Okayama-ken, Japan

Chuo-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

E7040-J081-301

Identifier Type: -

Identifier Source: org_study_id