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An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

An Uncontrolled Open Label Multicenter Phase II Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma (HCC)

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

- 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

- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Event Collection

Outcome Time Frame:

Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Germany: Bundesinstitut für Arzneimittel und Medizin-produkte (BfArM)

Study ID:




Start Date:

September 2009

Completion Date:

March 2013

Related Keywords:

  • Carcinoma, Hepatocellular
  • HCC
  • Safety
  • BAY73-4506
  • Carcinoma
  • Carcinoma, Hepatocellular