Evaluate Safety, Efficacy and Pharmacokinetics

Phase 2CompletedNCT01084863

Celltrion143 enrolled

Overview

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

Patients will receive CT-P6 or Herceptin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

143

Conditions

Metastatic Breast Cancer

Interventions

CT-P6DRUG

CT-P6: administered every 3 weeks

HerceptinDRUG

Herceptin: administered every 3 weeks

PaclitaxelDRUG

Paclitaxel: administered every 3 weeks

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Area Under the Concentration Time Curve at Steady State (AUCss)

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).

Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose

Secondary Outcomes

Trough Concentration at Steady State (CtroughSS)

Trough concentration at steady state (CtroughSS), defined as trough concentration at steady state. The secondary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).

Time frame: 3, 6, 12, 24, 72, 168, 336, 504 hours predose

Cardiotoxicity

Cardiac Ejection Fraction Assessment, defined as Mean change from baseline to endpoint assessment in left ventricular ejection fraction (LVEF, Unit: %) from the independent tumor review committee (ITRC).

Time frame: Up to approximately 1 year

Immunogenicity

Immunogenicity, defined as proportion of patients with antibodies to study drug (positive for antidrug antibody \[ADA\] result after the first study infusion).

Time frame: 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

Overall response rate (ORR) based on best overall response (BOR) during the Main Study Treatment Period and up to 1-year treatment from the independent tumor review committee (ITRC) and Investigator. ORR (complete response \[CR\] plus partial response \[PR\]), as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 To be assigned a best ORR of PR or CR, changes in tumour assessments must be confirmed no less than 4 weeks after the criteria for response were met.

Data from ClinicalTrials.gov

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