Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01003015
First received: October 2, 2009
Last updated: March 31, 2014
Last verified: March 2014

October 2, 2009
March 31, 2014
September 2009
November 2010   (final data collection date for primary outcome measure)
Adverse Event Collection [ Time Frame: Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01003015 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression ] [ Designated as safety issue: No ]
  • Trough concentration of Regorafenib and metabolites (for Europe only) [ Time Frame: Cycle 1 Day 15 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
  • Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) [ Time Frame: Cycle 1 Day 21 to Day 28 ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Trough concentration of Regorafenib and metabolites [ Time Frame: Cycle 1 and 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Drug: BAY73-4506
160 mg BAY73-4506
Experimental: Arm 1
Intervention: Drug: BAY73-4506
Bruix J, Tak WY, Gasbarrini A, Santoro A, Colombo M, Lim HY, Mazzaferro V, Wiest R, Reig M, Wagner A, Bolondi L. Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study. Eur J Cancer. 2013 Nov;49(16):3412-9. doi: 10.1016/j.ejca.2013.05.028. Epub 2013 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2013
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients aged equal or above 18 years.
  • BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
  • Liver function status Child-Pugh class A.
  • Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
  • Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of BAY73-4506.
  • ECOG PS of 0 or 1.
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
  • Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
  • Congestive heart failure NYHA>/= class 2
  • Unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Korea, Republic of,   Spain
 
NCT01003015
14596, 2009-012570-13
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2014

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