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

August 30, 2012
July 16, 2014
August 2012
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01677624 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypervascular Tumor and Arteriovenous Malformation
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 .
Experimental: E7040
Intervention: Device: E7040
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01677624
E7040-J081-301
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Shin Maeda Oncology Clinical Development Section Japan/Asia Clinical Research Product Creation Unit Eisai Product Creation Systems
Eisai Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP