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Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

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ClinicalTrials.gov Identifier: NCT01084863
Recruitment Status : Unknown
Verified August 2019 by Celltrion.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2010
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Description
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Brief Summary:
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: CT-P6 Drug: Herceptin Drug: Paclitaxel Phase 1 Phase 2

Detailed Description:
Patients will receive CT-P6 or Herceptin.
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Trastuzumab

Drug: Paclitaxel
Paclitaxel: administered every 3 weeks


Outcome Measures
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Primary Outcome Measures :
  1. PK parameter [ Time Frame: months ]

Secondary Outcome Measures :
  1. PK data, safety and efficacy [ Time Frame: months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084863


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: Investigational Site Samsung Medical Center
More Information
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01084863    
Other Study ID Numbers: CT-P6/1.1
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Keywords provided by Celltrion:
Herceptin
Her 2-positive
metastatic breast cancer
CT-P6
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological