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

NCT01204177 | Completed Phase 2

• 1 other identifier: 14899
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 15

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma (HCC); MEK inhibitor; Sorafenib; Disease control rate (DCR); Safety

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  From first dose of combination treatment until last tumor evaluation

Secondary Outcomes (8)

• Overall Survival (OS)

  1st dose of study medication to last date of follow up

• Time To Progression (TTP)

  1st dose of study medication until disease progression

• Response Rate (RR)

  1st dose of study medication until last tumor evaluation

• Duration Of Response (DOR)

  1st dose of study medication until last tumor evaluation

• Safety: physical examination, vital signs, adverse events, safety lab

  At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: BAY86-9766 MEK Inhibitor + Sorafenib

Interventions

BAY86-9766 MEK Inhibitor + Sorafenib DRUG

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)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (15)

Unknown Facility

Shatin, New Territories, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Singapore, 228510, Singapore

Location

Unknown Facility

Singapore, 258499, Singapore

Location

Unknown Facility

Junggu, Daegu Gwang''yeogsi, 700-721, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 410-769, South Korea

Location

Unknown Facility

Busan, 602-739, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Kaohsiung City, 833, Taiwan

Location

Unknown Facility

Tainan, 736, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Related Publications (1)

• Lim HY, Heo J, Choi HJ, Lin CY, Yoon JH, Hsu C, Rau KM, Poon RT, Yeo W, Park JW, Tay MH, Hsieh WS, Kappeler C, Rajagopalan P, Krissel H, Jeffers M, Yen CJ, Tak WY. A phase II study of the efficacy and safety of the combination therapy of the MEK inhibitor refametinib (BAY 86-9766) plus sorafenib for Asian patients with unresectable hepatocellular carcinoma. Clin Cancer Res. 2014 Dec 1;20(23):5976-85. doi: 10.1158/1078-0432.CCR-13-3445. Epub 2014 Oct 7.

  PMID: 25294897 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

HK (2); KR (7); SG (2); TW (4)