A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
Condition: Hypervascular Tumor and Arteriovenous Malformation
MeSH terms: Hemangioma; Arteriovenous Malformations; Congenital Abnormalities
Intervention: E7040
Intervention description: 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 .
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypervascular tumor; arteriovenous malformation; arterial embolization

Summary:

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

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.