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Completed

NCT Number: NCT02031731

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 mg/kg Onartuzumab (MetMAb)

Drug

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

15 mg/kg Onartuzumab (MetMAb)

Drug

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

30 mg/kg Onartuzumab (MetMAb)

Drug

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

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 1 year

  2. Total exposure of MetMAb, as measured by area under the concentration-time curve (AUC)

    Time frame: Up to 1 year

Secondary outcomes

  1. Incidence of anti-therapeutic antibodies against MetMAb

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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