Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT01084863
First received: March 5, 2010
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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 2013
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
Other Name: CT-P6
Drug: Paclitaxel
Paclitaxel: administered every 3 weeks
Other Name: Paclitaxel
Active Comparator: Herceptin & Paclitaxel
Trastuzumab + Paclitaxel
Drug: Herceptin
Herceptin: administered every 3 weeks
Other Name: Trastuzumab
Drug: Paclitaxel
Paclitaxel: administered every 3 weeks
Other Name: Paclitaxel

Detailed Description:

Patients will receive CT-P6 or Herceptin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084863

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

No publications provided

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: August 8, 2013
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Celltrion:
Herceptin
Her 2-positive
metastatic breast cancer
CT-P6

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014