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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031731
• Other study ID #: YO28211
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2014
• Last updated: March 10, 2017
• Start date: January 13, 2014
• Est. completion date: April 14, 2014

Study information

• Verified date: March 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 14, 2014
• Est. primary completion date: April 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• 4 mg/kg Onartuzumab (MetMAb)
4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
• 15 mg/kg Onartuzumab (MetMAb)
15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
• 30 mg/kg Onartuzumab (MetMAb)
30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	the First Hospital of Jilin University	Changchun
China	Sun Yet-sen University Cancer Center	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 1 year
Primary	Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)		Up to 1 year
Secondary	Incidence of anti-therapeutic antibodies against MetMAb		Up to 1 year