check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

14899

ClinicalTrials.gov Identifier:

NCT01204177

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessing BAY86-9766 plus sorafenib for the treatment of liver cancer.

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
70
Trial Dates
December 2010 - August 2013
Phase
Phase 2
Could I Receive a placebo
No
Products
Refametinib (BAY86-9766)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
OncoCare Cancer CentreSingapore, 258499, Singapore
Completed
Singapore Oncology ConsultationsSingapore, 228510, Singapore
Completed
Chi-Mei Medical Center, LiouyineTainan, 736, Taiwan
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
National Cheng Kung University HospitalTainan, Taiwan
Completed
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Completed
Prince of Wales HospitalShatin, Hong Kong
Completed
Queen Mary HospitalHong Kong, Hong Kong
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Terminated
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
National Cancer CenterGoyang-si, 410-769, Korea, Republic Of
Completed
Kyungpook National University HospitalJung-gu, 700-721, Korea, Republic Of
Completed
Pusan National University HospitalBusan, 602-739, Korea, Republic Of
Completed
Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of

Primary Outcome

  • Disease Control Rate (DCR)
    date_rangeTime Frame:
    From first dose of combination treatment until last tumor evaluation
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

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

Trial design

A phase II trial of BAY86-9766 plus sorafenib as first line systemic treatment for hepatocellular carcinoma (HCC)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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