A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
To evaluate the efficacy and safety of transcatheter arterial embolization with E7040 in
 Japanese subjects with hypervascular tumor or arteriovenous malformation
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.