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Evaluate Safety, Efficacy and Pharmacokinetics

NCT01084863 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2025-01-24

Study results available
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Summary

The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Conditions

Interventions

DRUG

CT-P6

CT-P6: administered every 3 weeks

DRUG

Herceptin

Herceptin: administered every 3 weeks

DRUG

Paclitaxel

Paclitaxel: administered every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Investigational Site · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-12-31
Completion
2023-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01084863 on ClinicalTrials.gov