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A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386 ) in Adult Japanese Participants With Advanced Solid Tumors

NCT02525536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-09-22

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.

Conditions

  • Neoplasms, Advanced Solid

Interventions

DRUG

Trebananib 3 mg/kg

Trebananib (AMG 386) 3 mg/kg, intravenous infusion.

DRUG

Trebananib 10 mg/kg

Trebananib (AMG 386) 10 mg/kg, intravenous infusion.

DRUG

Trebananib 30 mg/kg

Trebananib (AMG 386) 30 mg/kg, intravenous infusion.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

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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 NCT02525536 on ClinicalTrials.gov