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

Primary Purpose

Carcinoma, Hepatocellular

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BAY86-9766 MEK Inhibitor + Sorafenib
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular carcinoma (HCC), MEK inhibitor, Sorafenib, Disease control rate (DCR), Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Disease Control Rate (DCR)

Secondary Outcome Measures

Overall Survival (OS)
Time To Progression (TTP)
Response Rate (RR)
Duration Of Response (DOR)
Safety: physical examination, vital signs, adverse events, safety lab
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Biomarkers

Full Information

First Posted
September 16, 2010
Last Updated
September 5, 2013
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01204177
Brief Title
Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer.
Acronym
BASIL
Official Title
A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular carcinoma (HCC), MEK inhibitor, Sorafenib, Disease control rate (DCR), Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAY86-9766 MEK Inhibitor + Sorafenib
Intervention Description
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)
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Time Frame
From first dose of combination treatment until last tumor evaluation
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
1st dose of study medication to last date of follow up
Title
Time To Progression (TTP)
Time Frame
1st dose of study medication until disease progression
Title
Response Rate (RR)
Time Frame
1st dose of study medication until last tumor evaluation
Title
Duration Of Response (DOR)
Time Frame
1st dose of study medication until last tumor evaluation
Title
Safety: physical examination, vital signs, adverse events, safety lab
Time Frame
At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
Title
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)
Time Frame
At day 1 of each cycle and within 7 day after the last treatment
Title
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Time Frame
Day -3, cycle 2 (day 1)
Title
Biomarkers
Time Frame
At screening, day 1 of cycle 1 - 4, EOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Shatin
State/Province
New Territories
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Jung-gu
State/Province
Daegu Gwang''yeogsi
ZIP/Postal Code
700-721
Country
Korea, Republic of
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
410-769
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25294897
Citation
Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7.
Results Reference
derived

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

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