Evaluate Safety, Efficacy and Pharmacokinetics

Metastatic Breast Cancer Clinical Trial

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Official title:

Double-blind Randomised Phase I/IIb Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01084863
• Other study ID #: CT-P6/1.1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2010
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Patients will receive CT-P6 or Herceptin.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: December 2020
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Drug:
• CT-P6
CT-P6: administered every 3 weeks
• Herceptin
Herceptin: administered every 3 weeks
• Paclitaxel
Paclitaxel: administered every 3 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter		months
Secondary	PK data, safety and efficacy		months