A Double-Blind, Randomized, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics, and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Paclitaxel
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Celltrion
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration Time Curve at Steady State (AUCss)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
Detailed Description
Patients will receive CT-P6 or Herceptin.
Investigators
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
Arms & Interventions
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.
Intervention: Paclitaxel
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.
Intervention: CT-P6
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.
Intervention: Herceptin
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.
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Area Under the Concentration Time Curve at Steady State (AUCss)
Time Frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose
Area under the concentration time curve at steady state (AUCss), defined as area under the concentration-time curve between Cycle 8 to Cycle 9. The primary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).
Secondary Outcomes
- Trough Concentration at Steady State (CtroughSS)(3, 6, 12, 24, 72, 168, 336, 504 hours predose)
- Cardiotoxicity(Up to approximately 1 year)
- Immunogenicity(every 4 cycles (each cycle is 3 weeks), Up to approximately 5.5 years)
- Overall Response Rate (ORR; Complete Response [CR] Plus Partial Response [PR]) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1(every 6 weeks (up to cycle 4) or 12 weeks (after cycle 4) (every cycle is 3 weeks), up to 6 months in Main treatment period and up to 1 year)
- Serum Human Epidermal Growth Factor Receptor-2 (HER-2) Shed Antigen Value(day 1 of each cycle (every cycle is 3 weeks), Up to approximately 5.5 years)