Evaluate Safety, Efficacy and Pharmacokinetics

NCT01084863 | Completed Phase 1 Results DMC

• 1 other identifier: CT-P6/1.1
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Breast Cancer

Keywords

Herceptin; Her 2-positive; metastatic breast cancer; CT-P6

Outcome Measures

Primary Outcomes (1)

• 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).

  3, 6, 12, 24, 72, 168, 336, 504 hours predose

Secondary Outcomes (5)

• 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

Study Arms (2)

CT-P6 & Paclitaxel

EXPERIMENTAL

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.

Drug: CT-P6; Drug: Paclitaxel

Herceptin & Paclitaxel

ACTIVE COMPARATOR

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.

Drug: Herceptin; Drug: Paclitaxel

Interventions

CT-P6 DRUG

CT-P6: administered every 3 weeks

CT-P6 & Paclitaxel

Herceptin DRUG

Herceptin: administered every 3 weeks

Also known as: Trastuzumab

Herceptin & Paclitaxel

Paclitaxel DRUG

Paclitaxel: administered every 3 weeks

CT-P6 & Paclitaxel; Herceptin & Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CT-P6; Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Head of Clinical Planning Department
• Organization: Celltrion

contact@celltrion.com

82328505000

Study Officials

• Investigational Site

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 11, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-01

Locations

KR (1)