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

July 5, 2018 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase I Study of Pyrotinib in Patients With HER2 Positive Advanced Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18 and ≤70 years.
  • ECOG performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • At least one measurable lesion exists.(RECIST 1.1)
  • Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.

  • Required laboratory values including following parameters:

    • ANC: ≥ 1.5 x 109/L
    • Platelet count: ≥ 100 x 109/L
    • Hemoglobin: ≥ 9.0 g/dL
    • Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
    • ALT and AST: ≤ 1.5 x ULN
    • BUN and creatine clearance rate: ≥ 50 mL/min
    • LVEF: ≥ 50%
    • QTcF: < 470 ms
  • Signed informed consent.

Exclusion Criteria:

  • Subjects with third space fluid that can not be controled by drainage or other methods.
  • Steroid treatment for more than 50 days, or in need of long-term use of steroids.
  • Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  • Less than 4 weeks from the last radiotherapy,chemotherapy，surgery，hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  • Subjects with intracranial lesions.
  • Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.
  • Receiving any other antitumor therapy.
  • Less than 4 weeks from the last clinical trial.
  • Known history of hypersensitivity to pyrotinib or any of it components.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  • Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  • Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period.
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
  • Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
  • Known history of neurological or psychiatric disease, including epilepsy or dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pyrotinib
Each subject will receive a single dose of pyrotinib on day 1, followed by 4-day observation period, and then subject will receive pyrotinib once daily for 28 days during cycle 1.Each cycle will consists of 28 days.
Drug: Pyrotinib
Pyrotinib either at 80, 160, 240, 320, 400, 480 mg ....., p.o. once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events.
Time Frame: 8 weeks
8 weeks
Objective response rate (ORR).
Time Frame: 8 weeks
8 weeks
Pyrotinib pharmacokinetic parameter: Cmax.
Time Frame: 4 weeks
4 weeks
Pyrotinib pharmacokinetic parameter: Tmax.
Time Frame: 4 weeks
4 weeks
Pyrotinib pharmacokinetic parameter: t1/2.
Time Frame: 4 weeks
4 weeks
Pyrotinib pharmacokinetic parameter: AUC.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLTN-Ib

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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