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

NCT02031731 | Completed Phase 1

• 1 other identifier: YO28211
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of anti-therapeutic antibodies against MetMAb

  Up to 1 year

Study Arms (3)

4 mg/kg Onartuzumab (MetMAb)

EXPERIMENTAL

Drug: 4 mg/kg Onartuzumab (MetMAb)

15 mg/kg Onartuzumab (MetMAb)

EXPERIMENTAL

Drug: 15 mg/kg Onartuzumab (MetMAb)

30 mg/kg Onartuzumab (MetMAb)

EXPERIMENTAL

Drug: 30 mg/kg Onartuzumab (MetMAb)

Interventions

4 mg/kg Onartuzumab (MetMAb) DRUG

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

4 mg/kg Onartuzumab (MetMAb)

15 mg/kg Onartuzumab (MetMAb) DRUG

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

15 mg/kg Onartuzumab (MetMAb)

30 mg/kg Onartuzumab (MetMAb) DRUG

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

30 mg/kg Onartuzumab (MetMAb)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, 100142, China

Location

the First Hospital of Jilin University

Changchun, 130021, China

Location

Sun Yet-sen University Cancer Center

Guangzhou, 510060, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

onartuzumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: January 13, 2014
• Primary Completion: April 14, 2014
• Study Completion: April 14, 2014
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

CN (3)