Study 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

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

Trial summary

Enrollment Goal

Trial Dates

December 2010 - August 2013

Phase

Phase 2

Could I Receive a placebo

Products

Refametinib (BAY86-9766)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	OncoCare Cancer Centre	Singapore, 258499, Singapore
Completed	Singapore Oncology Consultations	Singapore, 228510, Singapore
Completed	Chi-Mei Medical Center, Liouyine	Tainan, 736, Taiwan
Completed	National Taiwan University Hospital	Taipei, 100, Taiwan
Completed	National Cheng Kung University Hospital	Tainan, Taiwan
Completed	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung, 833, Taiwan
Completed	Prince of Wales Hospital	Shatin, Hong Kong
Completed	Queen Mary Hospital	Hong Kong, Hong Kong
Completed	Samsung Medical Center	Seoul, 135-710, Korea, Republic Of
Terminated	Asan Medical Center	Seoul, 138-736, Korea, Republic Of
Completed	Seoul National University Hospital	Seoul, 110-744, Korea, Republic Of
Completed	National Cancer Center	Goyang-si, 410-769, Korea, Republic Of
Completed	Kyungpook National University Hospital	Jung-gu, 700-721, Korea, Republic Of
Completed	Pusan National University Hospital	Busan, 602-739, Korea, Republic Of
Completed	Yonsei University College of Medicine	Seoul, 120-752, Korea, Republic Of

Primary Outcome

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

Secondary Outcome

Overall Survival (OS)
Time Frame:
1st dose of study medication to last date of follow up
Safety Issue:
No
Time To Progression (TTP)
Time Frame:
1st dose of study medication until disease progression
Safety Issue:
No
Response Rate (RR)
Time Frame:
1st dose of study medication until last tumor evaluation
Safety Issue:
No
Duration Of Response (DOR)
Time Frame:
1st dose of study medication until last tumor evaluation
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
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
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)
Safety Issue:
No
Biomarkers
Time Frame:
At screening, day 1 of cycle 1 - 4, EOT
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

Additional Information

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