The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors

A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

This phase I study will examine the pharmacokinetics and safety of Onartuzumab (MetMAb) in chinese patients with locally advanced or metastatic solid tumors. Patients will be divided into 3 cohorts, which will each be given a different dose of MetMAb. The cohorts will be treated sequentially, starting with the lowest dose. MetMAb will be administered intravenously every 3 weeks. Patients may be treated for up to 16 cycles (21 days each) or 1 year, whichever occurs first, in the absence of disease progression.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: 4 mg/kg Onartuzumab (MetMAb); Drug: 15 mg/kg Onartuzumab (MetMAb); Drug: 30 mg/kg Onartuzumab (MetMAb)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Guangzhou, China, 510060
    • Sun Yet-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >/= 18 years
• Histologically confirmed locally advanced or metastatic solid tumor that does not respond to standard treatment or for which there is no further standard treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
• Use of effective contraception
• Life expectancy > 3 months

Exclusion Criteria:

• Brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation, and/or patients with brain metastasis that have been receiving corticosteroids.
• Previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression that has not been clinically stable for at least 2 months.
• Treatment with anti-tumor therapy within 4 weeks before the start of study treatment, with the following exception: Patients with metastatic prostate cancer on maintenance hormonal therapy, provided they meet all other eligibility criteria.
• Current, serious or uncontrolled, systemic illness.
• Recent stroke (within the past 6 months).
• Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs (NSAIDs).
• History of cardiovascular conditions.
• Any other disease, gastrointestinal abnormality, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
• Receipt of any investigational agent, or participation in any other clinical study, within 4 weeks before the start of study treatment.
• Major surgery within 4 weeks before the start of study treatment, without complete recovery.
• Significant traumatic injury within 3 weeks before the start of study treatment (All wounds must be fully healed prior to Day 1).
• Uncontrolled excess calcium levels.
• Known human immunodeficiency virus (HIV) infection.
• Inadequate organ function
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 mg/kg Onartuzumab (MetMAb)	Drug: 4 mg/kg Onartuzumab (MetMAb); 4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
Experimental: 15 mg/kg Onartuzumab (MetMAb)	Drug: 15 mg/kg Onartuzumab (MetMAb); 15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
Experimental: 30 mg/kg Onartuzumab (MetMAb)	Drug: 30 mg/kg Onartuzumab (MetMAb); 30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to 1 year
Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of anti-therapeutic antibodies against MetMAb	Up to 1 year

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2014
• Primary Completion (Actual): April 14, 2014
• Study Completion (Actual): April 14, 2014

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: YO28211