Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: March 5, 2010
Last updated: February 11, 2015
Last verified: February 2015
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Condition Intervention Phase
Metastatic Breast Cancer
Drug: CT-P6
Drug: Herceptin
Drug: Paclitaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomised Phase I/IIb Study

Resource links provided by NLM:

Further study details as provided by Celltrion:

Primary Outcome Measures:
  • PK parameter [ Time Frame: months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK data, safety and efficacy [ Time Frame: months ] [ Designated as safety issue: Yes ]

Enrollment: 174
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Patients will receive CT-P6 or Herceptin.

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084863

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Principal Investigator: Investigational Site Samsung Medical Center
  More Information

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01084863     History of Changes
Other Study ID Numbers: CT-P6/1.1 
Study First Received: March 5, 2010
Last Updated: February 11, 2015
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Celltrion:
Her 2-positive
metastatic breast cancer

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on May 02, 2016