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Compare: Evaluate Safety, Efficacy and Pharmacokinetics

Sponsor
Celltrion (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01084863
Collaborator
(none)
174
Enrollment
1
Location
2
Arms
130
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Patients will receive CT-P6 or Herceptin.

Study Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Double-blind Randomised Phase I/IIb Study
Actual Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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: Herceptin
Herceptin: administered every 3 weeks
Other Names:
  • Trastuzumab

    • Drug: Paclitaxel
    Paclitaxel: administered every 3 weeks

    Outcome Measures

    Primary Outcome Measures

    1. PK parameter [months]

    Secondary Outcome Measures

    1. PK data, safety and efficacy [months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Celltrion

    Investigators

    • Principal Investigator: Investigational Site, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celltrion
    ClinicalTrials.gov Identifier:
    NCT01084863
    Other Study ID Numbers:
    • CT-P6/1.1
    First Posted:
    Mar 11, 2010
    Last Update Posted:
    Aug 9, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Celltrion
    Herceptin
    Her 2-positive
    metastatic breast cancer
    CT-P6
    Additional relevant MeSH terms:
    Breast Neoplasms
    Paclitaxel
    Trastuzumab

    Study Results

    No Results Posted as of Aug 9, 2019