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Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

Primary Purpose

Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT-P6
Herceptin
Paclitaxel
Sponsored by
Celltrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Herceptin, Her 2-positive, metastatic breast cancer, CT-P6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CT-P6 & Paclitaxel

Herceptin & Paclitaxel

Arm Description

CT-P6 + Paclitaxel

Trastuzumab + Paclitaxel

Outcomes

Primary Outcome Measures

PK parameter

Secondary Outcome Measures

PK data, safety and efficacy

Full Information

First Posted
March 5, 2010
Last Updated
August 7, 2019
Sponsor
Celltrion
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1. Study Identification

Unique Protocol Identification Number
NCT01084863
Brief Title
Evaluate Safety, Efficacy and Pharmacokinetics
Acronym
Compare
Official Title
Double-blind Randomised Phase I/IIb Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Detailed Description
Patients will receive CT-P6 or Herceptin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Herceptin, Her 2-positive, metastatic breast cancer, CT-P6

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-P6 & Paclitaxel
Arm Type
Active Comparator
Arm Description
CT-P6 + Paclitaxel
Arm Title
Herceptin & Paclitaxel
Arm Type
Active Comparator
Arm Description
Trastuzumab + Paclitaxel
Intervention Type
Drug
Intervention Name(s)
CT-P6
Intervention Description
CT-P6: administered every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Herceptin
Other Intervention Name(s)
Trastuzumab
Intervention Description
Herceptin: administered every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel: administered every 3 weeks
Primary Outcome Measure Information:
Title
PK parameter
Time Frame
months
Secondary Outcome Measure Information:
Title
PK data, safety and efficacy
Time Frame
months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Investigational Site
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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