Clinical trial NCT02031731: The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
Official title: A PHASE I STUDY OF THE PHARMACOKINETICS AND SAFETY OF ONARTUZUMAB IN CHINESE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 1 year
measure: Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Incidence of anti-therapeutic antibodies against MetMAb
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: