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

Inclusion criteria:

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

2. Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumorconfirmed by dynamic computerized tomography (CT) after bolus intravenous infusion ofcontrast media and have a typical finding of hypervascular tumor, and are not amenableto resection and local therapy, and meet any of the following (a) to (c).

3. 1 lesion of >50 mm in diameter

4. 2 or 3 lesions of >30 mm in at least one diameter

5. 4 or more lesions

6. Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deepstained early stage tumor confirmed by dynamic CT after bolus intravenous infusion ofcontrast media and have a typical finding of hypervascular tumor but not amenable toresection, and whose primary lesion and extrahepatic lesion are controlled.

7. Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stainedearly stage tumor confirmed by dynamic CT after bolus injection of contrast media andwho have a typical finding of hypervascular tumor other than the liver (e.g., renalcell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b).

8. Subjects applicable to pre-operative arterial embolization therapy to reducetumor size or volume of bleeding for safer conduct of surgical resection or localtherapy (e.g., radiofrequency ablation (RFA))

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

10. Arteriovenous malformation: Subjects with arteriovenous malformation (except for central nervous system, heart, andlung) confirmed by dynamic CT but at a low risk of undesirable reflux into systemiccirculation and with vessel malformation suitable for particle embolization in size

11. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (PS 0-1 for metastatic hepatic cancer)

12. No carry-over effect of prior therapy or adverse drug reactions which may influence theembolic effect of E7040, if having a history of prior therapy time elapsed from the end ofprior therapy to the start of E7040 embolization therapy should be: Surgery: greater thanor equal to 6 weeks Local therapy: greater than or equal to 4 weeks Embolization fornon-target vessel: greater than or equal to 4 weeks

13. With a survival of greater than or equal to 12 months after the prior arterialembolization therapy using E7040

Exclusion criteria:

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

2. Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings inpatients 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, resectionin 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 thosewith a possible risk of influx of embolized particles into the central nervous system.