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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01897038
First received: July 8, 2013
Last updated: May 11, 2015
Last verified: May 2015

July 8, 2013
May 11, 2015
September 2013
March 2015   (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 cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated 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.
 
Completed
9
March 2015
March 2015   (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 information is only displayed when the study is recruiting subjects
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
May 2015

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