Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments ct-p6, herceptin, paclitaxel
Phase phase 1/phase 2
Target HER2
Sponsor Celltrion
Start date January 2010
End date December 2011
Trial size 174 participants
Trial identifier NCT01084863, CT-P6/1.1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
CT-P6 + Paclitaxel
ct-p6 CT-P6
CT-P6: administered every 3 weeks
paclitaxel Paclitaxel
Paclitaxel: administered every 3 weeks
(Active Comparator)
Trastuzumab + Paclitaxel
herceptin Trastuzumab
Herceptin: administered every 3 weeks
paclitaxel Paclitaxel
Paclitaxel: administered every 3 weeks

Primary Outcomes

Measure
PK parameter
time frame: months

Secondary Outcomes

Measure
PK data, safety and efficacy
time frame: months

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Double-blind Randomised Phase I/IIb Study
Principal investigator Investigational Site
Description Patients will receive CT-P6 or Herceptin.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Celltrion.