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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01677624
First received: August 30, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Hypervascular Tumor and Arteriovenous Malformation
Device: E7040
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To evaluate the efficacy of study device with E7040, success rate of embolization in the target vessel and operability of transcatheter arterial embolization [ Time Frame: up to 12 weeks after the treatment start ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E7040 Device: 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 .

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01677624

Locations
Japan
Hirosaki, Aomori, Japan
Chikushino, Fukuoka, Japan
Kurume, Fukuoka, Japan
Nishinomiya, Hyogo, Japan
Kanazawa, Ishikawa, Japan
Tsu, Mie, Japan
Chuo-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Kagoshima, Japan
Okayama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Shin Maeda Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01677624     History of Changes
Other Study ID Numbers: E7040-J081-301
Study First Received: August 30, 2012
Last Updated: July 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Hypervascular tumor
arteriovenous malformation
arterial embolization

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014