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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01003015
Other study ID # 14596
Secondary ID 2009-012570-13
Status Completed
Phase Phase 2
First received October 2, 2009
Last updated April 2, 2015
Start date September 2009
Est. completion date March 2013

Study information

Verified date April 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Bundesinstitut für Arzneimittel und Medizin-produkte (BfArM)Italy: Agenzia Italiana del Farmaco (AIFA)Spain:Agencia Española de Medicamentos y Productos Sanitarios (AGEMED)Korea: Korea Food & Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date March 2013
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
BAY73-4506
160 mg BAY73-4506

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Italy,  Korea, Republic of,  Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Event Collection Up to 30+/- 7 days after permanently discontinuing BAY73-4506 administration Yes
Secondary Time to progression Every 6 weeks during treatment and after 6 cycle treatment every 18 weeks till progression No
Secondary Objective response rate Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression No
Secondary Disease control rate Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression No
Secondary Overall survival Every 6 weeks during treatmen and after 6 cycle treatment every 18 weeks till progression No
Secondary Trough concentration of Regorafenib and metabolites (for Europe only) Cycle 1 Day 15 and Cycle 2 Day 1 No
Secondary Full Pharmacokinetics profile of BAY73-4506 and metabolites (for Korea only) Cycle 1 Day 21 to Day 28 No
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