Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

August 7, 2019 updated by: Celltrion

Double-blind Randomised Phase I/IIb Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will receive CT-P6 or Herceptin.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Are females
  • Have a Her 2 over-expression
  • Have ECOG 0 or 1

Exclusion Criteria:

  • Current clinical or radiographic evidence CNS metastases
  • Current Known infection
  • Pregnant or nursing mother

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CT-P6 & Paclitaxel
CT-P6 + Paclitaxel
Drug: CT-P6
CT-P6: administered every 3 weeks
Drug: Paclitaxel
Paclitaxel: administered every 3 weeks
Active Comparator: Herceptin & Paclitaxel
Trastuzumab + Paclitaxel
Drug: Paclitaxel
Paclitaxel: administered every 3 weeks
Drug: Herceptin
Herceptin: administered every 3 weeks
Other Names:
  • Trastuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameter
Time Frame: months
months

Secondary Outcome Measures

Outcome Measure
Time Frame
PK data, safety and efficacy
Time Frame: months
months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Principal Investigator: Investigational Site, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Actual)

August 9, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P6/1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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