The Pharmacokinetics and Safety of Onartuzumab (MetMAb) in Chinese Patients With Locally Advanced or Metastatic Solid Tumors
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Drug: 4 mg/kg Onartuzumab (MetMAb)Drug: 15 mg/kg Onartuzumab (MetMAb)Drug: 30 mg/kg Onartuzumab (MetMAb)
- Registration Number
- NCT02031731
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 mg/kg Onartuzumab (MetMAb) 4 mg/kg Onartuzumab (MetMAb) - 15 mg/kg Onartuzumab (MetMAb) 15 mg/kg Onartuzumab (MetMAb) - 30 mg/kg Onartuzumab (MetMAb) 30 mg/kg Onartuzumab (MetMAb) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of anti-therapeutic antibodies against MetMAb Up to 1 year
Trial Locations
- Locations (3)
Sun Yet-sen University Cancer Center
🇨🇳Guangzhou, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Beijing Cancer Hospital
🇨🇳Beijing, China