Clinical trial · Interventional
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)
NCT01003015CI-TRIAL-00017388completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY73-4506 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: BAY73-4506
Primary outcomes (1)
- measure
- Adverse Event Collection
- timeFrame
- Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration
Secondary outcomes (6)
- measure
- Time to progression
- timeFrame
- Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression
- measure
- Objective response rate
- timeFrame
- Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBruix 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. PMID 23809766