NCT01084863CompletedPhase 1/2
Evaluate Safety, Efficacy and Pharmacokinetics
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 143 (actual)
- First submitted
- 5 Mar 2010
- Start date
- Feb 2010
- Primary completion date
- Dec 2011
- Lead sponsor
- Celltrion
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01084863
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 143
- From Feb 2010 to the primary completion date, Dec 2011
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current Known infection
Other
- Current clinical or radiographic evidence central nervous system (CNS) metastases
- Pregnant or nursing mother
Who the study is looking for
- Are females
- Have a Her 2 over-expression
- Have Eastern Cooperative Oncology Group (ECOG) 0 or 1
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.