Estudio fase II de seguridad, abierto, no controlado, multicéntrico con BAY 73-4506 en pacientes con carcinoma hepatocelular (HCC) (An uncontrolled open label multicenter phase II safety study of BAY 73-4506 in patients with hepatocellular carcinoma (HCC))

• Conditions: Carcinoma hepatocelular en pacientes que han progresado radiológicamente a un tratamiento anticancerígeno previo.; MedDRA version: 12.0Level: LLTClassification code 10049010Term: Carcinoma hepatocellular

• Registration Number: EUCTR2009-012570-13-ES
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-31
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

*Male or female patients aged equal or above18 years.
*Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per AASLD criteria.
*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 BAY 73-4506.
*Recovery from any previous drug/procedure-related toxicity to CTC Grade 0 or 1 levels (except alopecia), or to baseline preceding the prior treatment.
*ECOG PS of 0 or 1.
*Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted (Modified diet in renal disease) abbreviated formula
*At least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to Response Evaluation Criteria (RECIST) and JNCI amendments regarding characterization of lesions in HCC
*Life expectancy of at least 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

*Prior treatment with BAY 73-4506.
*Large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices should be performed by endoscopy within 6 months of study start, and within 12 months for patients in whom conventional medical intervention for known esophageal varices is already in place.
*Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
*Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or basal cell epithelioma. Any cancer curatively treated > 5 years prior to study entry is permitted.
*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).
*Major surgical procedure or significant traumatic injury within 28 days before start of study medication.
*Pregnant or breast-feeding patients.
*Congestive heart failure NYHA>= class 2
*Unstable angina (angina symptoms at rest, new ?onset angina ie, 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).
*Patients with phaeochromocytoma.
*Ongoing infection > Grade 2 NCI-CTC version 3.0.
*Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample).
*Clinically significant bleeding within 30 days before start of study medication.
*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.
*Dehydration NCI-CTC version 3.0 Grade ? 1.
*Unresolved toxicity higher than NCI-CTCAE (version 3.0) Grade 1 (excluding alopecia) attributed to any prior therapy/procedure.
*Any illness or medical condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study.
*Known history of human immunodeficiency virus (HIV) infection.
*Patients with seizure disorder requiring medication.
*History of organ allograft.
*Non-healing wound, ulcer, or bone fracture.
*Renal failure requiring hemo-or peritoneal dialysis.
*Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results.
*Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
*Patients unable to swallow oral medications.
*Interstitial lung disease with ongoing signs and symptoms at the time of screening.
*Any malabsorption condition.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified