Evaluate Safety, Efficacy and Pharmacokinetics

NCT ID: NCT01084863

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2023-12-31

Brief Summary

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

Detailed Description

Patients will receive CT-P6 or Herceptin.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CT-P6 & Paclitaxel

CT-P6 was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (CT-P6). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation.

Group Type: EXPERIMENTAL

CT-P6

Intervention Type: DRUG

CT-P6: administered every 3 weeks

Paclitaxel

Intervention Type: DRUG

Paclitaxel: administered every 3 weeks

Herceptin & Paclitaxel

Herceptin was administered at a loading dose of 8 mg/kg body weight by IV infusion over 90 minutes on Day 1, Cycle 1, then at 6 mg/kg repeated at 3-weekly intervals until disease progression, death, or discontinuation.

Paclitaxel was administered at a dose of 175 mg/m2 body surface area (BSA) as a continuous 3-hour IV infusion on the day following the first dose of study drug (Herceptin). If the first dose of study drug was well tolerated, subsequent doses of paclitaxel were given immediately after the next dose of study drug. Paclitaxel cycles were repeated every 3 weeks until disease progression, death, intolerable toxicity, or discontinuation.

Group Type: ACTIVE_COMPARATOR

Herceptin

Intervention Type: DRUG

Herceptin: administered every 3 weeks

Paclitaxel

Intervention Type: DRUG

Paclitaxel: administered every 3 weeks

Interventions

CT-P6

CT-P6: administered every 3 weeks

Intervention Type: DRUG

Herceptin

Herceptin: administered every 3 weeks

Intervention Type: DRUG

Paclitaxel

Paclitaxel: administered every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Trastuzumab

Eligibility Criteria

Inclusion Criteria

• Are females
• Have a Her 2 over-expression
• Have Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria

• Current clinical or radiographic evidence central nervous system (CNS) metastases
• Current Known infection
• Pregnant or nursing mother

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Investigational Site

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CT-P6/1.1

Identifier Type: -

Identifier Source: org_study_id