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Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer

NCT01937689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-09

No results posted yet for this study

Summary

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer:

* To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD)
* To determine the dose-limiting toxicity (DLT)
* To determine the pharmacokinetic profile of Pyrotinib and its metabolites
* To assess preliminary antitumor activity
* To determine preliminary regimen dose for phase II study
* To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Conditions

Interventions

DRUG

Pyrotinib

Pyrotinib either at 80, 160, 240, 320, 400, 480 mg ....., p.o. once daily.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937689 on ClinicalTrials.gov