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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01204177
First received: September 16, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Drug: BAY86-9766 MEK Inhibitor + Sorafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Disease Control Rate (DCR) [ Time Frame: From first dose of combination treatment until last tumor evaluation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 1st dose of study medication to last date of follow up ] [ Designated as safety issue: No ]
  • Time To Progression (TTP) [ Time Frame: 1st dose of study medication until disease progression ] [ Designated as safety issue: No ]
  • Response Rate (RR) [ Time Frame: 1st dose of study medication until last tumor evaluation ] [ Designated as safety issue: No ]
  • Duration Of Response (DOR) [ Time Frame: 1st dose of study medication until last tumor evaluation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients) [ Time Frame: Day -3, cycle 2 (day 1) ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: At screening, day 1 of cycle 1 - 4, EOT ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2010
Study Completion Date: August 2013
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204177

Locations
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, 120-752
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Singapore
Singapore, Singapore, 258499
Singapore, Singapore, 228510
Taiwan
Kaohsiung, Taiwan, 833
Tainan, Taiwan, 736
Tainan, Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01204177     History of Changes
Other Study ID Numbers: 14899
Study First Received: September 16, 2010
Last Updated: September 5, 2013
Health Authority: Korea: Food and Drug Administration
Taiwan: Department of Health
Singapore: Ministry of Health
Hong Kong: Department of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014