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

September 5, 2013 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: From first dose of combination treatment until last tumor evaluation
From first dose of combination treatment until last tumor evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 1st dose of study medication to last date of follow up
1st dose of study medication to last date of follow up
Time To Progression (TTP)
Time Frame: 1st dose of study medication until disease progression
1st dose of study medication until disease progression
Response Rate (RR)
Time Frame: 1st dose of study medication until last tumor evaluation
1st dose of study medication until last tumor evaluation
Duration Of Response (DOR)
Time Frame: 1st dose of study medication until last tumor evaluation
1st dose of study medication until last tumor evaluation
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
At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT
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
At day 1 of each cycle and within 7 day after the last treatment
Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients)
Time Frame: Day -3, cycle 2 (day 1)
Day -3, cycle 2 (day 1)
Biomarkers
Time Frame: At screening, day 1 of cycle 1 - 4, EOT
At screening, day 1 of cycle 1 - 4, EOT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14899

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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