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

NCT ID: NCT02031731

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-13
• Study Completion Date: 2014-04-14

Brief Summary

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4 mg/kg Onartuzumab (MetMAb)

Group Type: EXPERIMENTAL

4 mg/kg Onartuzumab (MetMAb)

Intervention Type: DRUG

4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

15 mg/kg Onartuzumab (MetMAb)

Group Type: EXPERIMENTAL

15 mg/kg Onartuzumab (MetMAb)

Intervention Type: DRUG

15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

30 mg/kg Onartuzumab (MetMAb)

Group Type: EXPERIMENTAL

30 mg/kg Onartuzumab (MetMAb)

Intervention Type: DRUG

30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

Interventions

4 mg/kg Onartuzumab (MetMAb)

4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

Intervention Type: DRUG

15 mg/kg Onartuzumab (MetMAb)

15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

Intervention Type: DRUG

30 mg/kg Onartuzumab (MetMAb)

30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing Cancer Hospital

Beijing, , China

the First Hospital of Jilin University

Changchun, , China

Sun Yet-sen University Cancer Center

Guangzhou, , China

Countries

China

Other Identifiers

YO28211

Identifier Type: -

Identifier Source: org_study_id