A Study of Onartuzumab as Single Agent and in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01897038
First received: July 8, 2013
Last updated: August 11, 2014
Last verified: August 2014

July 8, 2013
August 11, 2014
September 2013
September 2014   (final data collection date for primary outcome measure)
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: up to 42 days ] [ Designated as safety issue: Yes ]
  • Incidence, nature and severity of adverse events, graded according to the NCI CTCAE v4.0 [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01897038 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Steady-state plasma sorafenib concentrations when administered in combination with onartuzumab [ Time Frame: Day 1 Cycles 1-4 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
  • Progression-free survival at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Incidence of anti-therapeutic antibodies (ATAs) against onartuzumab [ Time Frame: up to approximately 31 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Onartuzumab as Single Agent and in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma
A PHASE Ib, OPEN-LABEL STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ONARTUZUMAB GIVEN AS A SINGLE AGENT AND IN COMBINATION WITH SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA (HCC)

This multicenter, open-label study will evaluate the maximum tolerated dose (MTD

) and dose-limiting toxicities of onartuzumab as single agent and in combination with sorafenib in patients with advanced hepatocellular carcinoma. Patients in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle.

Patients in Cohorts 2 and 3 will receive onartuzumab on Day 1 of each 21-day cy cle in combination with sorafenib 400 mg orally daily or twice daily. Anticipate d time on study treatment is until disease progression or unacceptable toxicity occurs.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cancer
  • Drug: onartuzumab
    Multiple doses
  • Drug: sorafenib
    400 mg QD or BID
  • Experimental: Cohort 1
    Intervention: Drug: onartuzumab
  • Experimental: Cohorts 2/3
    Interventions:
    • Drug: onartuzumab
    • Drug: sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Cytologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC)
  • Advanced or metastatic disease
  • Child-Pugh class A liver function
  • Measurable disease as defined by RECIST 1.1

Exclusion Criteria:

  • Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone
  • Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation.
  • Granulocyte count < 1500/mm3, platelet count < 75,000/ mm3, and hemoglobin < 8 g/dL within 7 days prior to Cycle 1 Day 1
  • Total bilirubin > 1.5 ×ULN
  • AST (SGOT), ALT (SGPT), alkaline phosphatase (ALP) > 5 ×ULN
  • Serum creatinine > 1.5 × ULN or creatinine clearance < 60 cc/min by Cockcroft-Gault formula
  • Significant history of cardiac disease within 6 months prior to Cycle 1 Day 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication
  • Serious active infection, or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment, with the exception of HBV and HCV infections
  • Known active infection with human immunodeficiency virus (HIV) or known HIV-seropositivity
  • Inability to take oral medication or untreated malabsorption syndrome
  • Pregnant or lactating women
  • History of transplantation including organ, bone marrow transplantation, and peripheral blood stem cell transplantation with the exception of corneal transplantation
  • Active bleeding diathesis (including active esophageal varices) within 8 weeks prior to Cycle 1 Day1 that are not successfully treated
  • Uncontrolled hypertension
  • Treatment with any other investigational drug within 4 weeks of Cycle 1 Day 1
Both
18 Years and older
No
Contact: Reference Study ID Number: GO28651 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Hong Kong,   Singapore,   Taiwan
 
NCT01897038
GO28651
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP