Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.

Carcinoma, Hepatocellular Clinical Trial

— BASIL  

Official title:

A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204177
• Other study ID #: 14899
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2010
• Last updated: September 5, 2013
• Start date: December 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationTaiwan: Department of HealthSingapore: Ministry of HealthHong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2013
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female age >/= 18 years of age

• Life expectancy >/= 12 weeks

• Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic

• Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period

• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1

• Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1

• Adequate bone marrow, liver and renal function

Exclusion Criteria:

• Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.

• History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension

• Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days

• Renal failure requiring hemo- or peritoneal dialysis

• Known human immunodeficiency virus (HIV) infection

• Known history or symptomatic metastatic brain or meningeal tumors

• History of organ allograft.

• History of interstitial lung disease (ILD).

• Excluded previous therapies and medications:

• Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy

• Radiotherapy within 4 weeks prior to start of study treatment

• Any other investigational agents within 4 weeks from the first dose of study treatment

• Major surgery within 4 weeks of start of study

• Concomitant use of strong inhibitors and strong inducers of CYP3A4

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• BAY86-9766 MEK Inhibitor + Sorafenib
All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR)		From first dose of combination treatment until last tumor evaluation	No
Secondary	Overall Survival (OS)		1st dose of study medication to last date of follow up	No
Secondary	Time To Progression (TTP)		1st dose of study medication until disease progression	No
Secondary	Response Rate (RR)		1st dose of study medication until last tumor evaluation	No
Secondary	Duration Of Response (DOR)		1st dose of study medication until last tumor evaluation	No
Secondary	Safety: physical examination, vital signs, adverse events, safety lab		At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT	Yes
Secondary	Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)		At day 1 of each cycle and within 7 day after the last treatment	No
Secondary	Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)		Day -3, cycle 2 (day 1)	No
Secondary	Biomarkers		At screening, day 1 of cycle 1 - 4, EOT	No

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