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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204177
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : September 6, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: BAY86-9766 MEK Inhibitor + Sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)
Study Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 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)

Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: From first dose of combination treatment until last tumor evaluation ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1st dose of study medication to last date of follow up ]
  2. Time To Progression (TTP) [ Time Frame: 1st dose of study medication until disease progression ]
  3. Response Rate (RR) [ Time Frame: 1st dose of study medication until last tumor evaluation ]
  4. Duration Of Response (DOR) [ Time Frame: 1st dose of study medication until last tumor evaluation ]
  5. 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 ]
  6. 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 ]
  7. Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients) [ Time Frame: Day -3, cycle 2 (day 1) ]
  8. Biomarkers [ Time Frame: At screening, day 1 of cycle 1 - 4, EOT ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01204177

Hong Kong
Shatin, New Territories, Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
Jung-gu, Daegu Gwang''yeogsi, Korea, Republic of, 700-721
Goyang-si, Gyeonggido, Korea, Republic of, 410-769
Busan, Korea, Republic of, 602-739
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 138-736
Singapore, Singapore, 228510
Singapore, Singapore, 258499
Kaohsiung, Taiwan, 833
Tainan, Taiwan, 736
Tainan, Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT01204177     History of Changes
Other Study ID Numbers: 14899
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013

Keywords provided by Bayer:
Hepatocellular carcinoma (HCC)
MEK inhibitor
Disease control rate (DCR)

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs