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

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: BAY86-9766 MEK Inhibitor + Sorafenib

• Registration Number: NCT01204177
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-12
• Primary Completion: 2011-08
• Study Completion: 2013-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	BAY86-9766 MEK Inhibitor + Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	From first dose of combination treatment until last tumor evaluation

Secondary Outcome Measures

Name	Time	Method
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
Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL)	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)	Day -3, cycle 2 (day 1)
Biomarkers	At screening, day 1 of cycle 1 - 4, EOT