Evaluate Safety, Efficacy and Pharmacokinetics (Compare)

Celltrion Healthcare

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Breast Cancer

Treatments: Drug: Herceptin; Drug: Paclitaxel; Drug: CT-P6

Study type: Interventional

Funder types: Industry

Identifiers

NCT01084863

CT-P6/1.1

Details and patient eligibility

About

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

Full description

Patients will receive CT-P6 or Herceptin.

Enrollment: 143 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups

CT-P6 & Paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: CT-P6

Drug: Paclitaxel

Herceptin & Paclitaxel

Active Comparator group

Description:

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.

Treatment:

Drug: Paclitaxel

Drug: Herceptin