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

NCT02031731 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-03-14

No results posted yet for this study

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

Interventions

DRUG

4 mg/kg Onartuzumab (MetMAb)

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

DRUG

15 mg/kg Onartuzumab (MetMAb)

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

DRUG

30 mg/kg Onartuzumab (MetMAb)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-13
Primary Completion
2014-04-14
Completion
2014-04-14

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02031731 on ClinicalTrials.gov