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Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01084863
Recruitment Status : Active, not recruiting
First Posted : March 11, 2010
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

Tracking Information
First Submitted Date  ICMJE March 5, 2010
First Posted Date  ICMJE March 11, 2010
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE February 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2010)
PK parameter [ Time Frame: months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Pharmacokinetics-AUCSS [ Time Frame: 6 months ]
to demonstrate equivalent pharmacokinetics (PK) in terms of area under the curve at steady state (AUCSS) between CT P6 and the comparator, Herceptin, in patients with metastatic breast cancer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2010)
PK data, safety and efficacy [ Time Frame: months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
PK data, safety and efficacy [ Time Frame: 6 months ]
to obtain additional comparative PK data, as well as initial safety and efficacy data with CT P6 in comparison to Herceptin in patients with metastatic breast cancer
  • Trough concentration at steady state (CtroughSS)
  • Cardiotoxicity, as assessed by mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF)
  • Immunogenicity, as assessed by the proportion of patients with development of antibodies to study drug
  • Overall Response Rate (ORR)
  • Change from baseline in serum Her-2 shed antigen
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Safety, Efficacy and Pharmacokinetics
Official Title  ICMJE Double-blind Randomised Phase I/IIb Study
Brief Summary The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Detailed Description Patients will receive CT-P6 or Herceptin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: CT-P6
    CT-P6: administered every 3 weeks
  • Drug: Herceptin
    Herceptin: administered every 3 weeks
    Other Name: Trastuzumab
  • Drug: Paclitaxel
    Paclitaxel: administered every 3 weeks
Study Arms  ICMJE
  • Active Comparator: CT-P6 & Paclitaxel
    CT-P6 + Paclitaxel
    Interventions:
    • Drug: CT-P6
    • Drug: Paclitaxel
  • Active Comparator: Herceptin & Paclitaxel
    Trastuzumab + Paclitaxel
    Interventions:
    • Drug: Herceptin
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2011)
174
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
130
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries Bulgaria,   Latvia,   Lithuania,   Serbia,   Taiwan,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT01084863
Other Study ID Numbers  ICMJE CT-P6/1.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Investigational Site Samsung Medical Center
PRS Account Celltrion
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP