Open-label, Single-arm Phase II Study of Trastuzumab and Pyrotinib Combination Regimen in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma Refractory to Standard Therapies

Chinese Academy of Medical Sciences1 site in 1 country30 target enrollmentMarch 10, 2022

ConditionsCarcinoma, Transitional Cell HER-2 Gene Amplification

InterventionsTrastuzumab

DrugsTrastuzumab

Overview

Phase: Phase 2
Intervention: Trastuzumab
Conditions: Carcinoma, Transitional Cell
Sponsor: Chinese Academy of Medical Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: ORR
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A open-label, single-arm, phase II trial to study was designed to evaluate the effectiveness and safety of trastuzumab and pyrotinib in treating HER2 positive patients who have previously treated, locally advanced, or metastatic urothelial carcinoma.

Registry

clinicaltrials.gov

Start Date

March 10, 2022

End Date

December 10, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese Academy of Medical Sciences

Responsible Party

Principal Investigator

Aiping Zhou

Vice director of Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent form
•Locally advanced or metastatic histologically confirmed transitional cell carcinoma of the urothelium, including the bladder, urethra, ureter, or renal pelvis
•18 years and older
•HER2 expression (3+ or 2+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization
•Relapsed from or failed at least one prior standard systemic chemotherapy regimen, including immunotherapy, HER2 ADC durgs, and chemothearpy containing cisplatin, carboplatin, paclitaxel, docetaxel, or gemcitabine
•At least 1 measurable lesion could be evaluated by RECIST v1.1
•Performance status: ECOG 0-1
•Life expectancy more than 12 weeks
•Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
•Good organ function:

Exclusion Criteria

•Have received trastuzumab or pyrotinib treatment in the past
•Known to have allergic reactions to any ingredients or excipients of experimental drugs
•Radiotherapy, RFA, interventional therapy or surgery were performed within 28 days before the first medication (except for previous diagnostic biopsy)
•Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
•Clinically significant ascites
•Brain metastasis or meningeal metastasis with neurological symptoms
•Diabetes was not controlled, defined as HbA1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmHg after antihypertensive drug
•Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
•Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
•Pregnant or nursing

Arms & Interventions

Trastuzumab + Pyrotinib

Patients receive a loading dose of trastuzumab IV over 90 minutes on day 1 of week 1. For all subsequent doses, patients receive trastuzumab IV over 30 minutes every three weeks. Meanwhile, patients also receive pyrotinib 400mg PO daily. Treatment may continue till unacceptable toxicity or disease progression occurs.

Intervention: Trastuzumab

Outcomes

Primary Outcomes

ORR

Time Frame: 1 year

Objective response rate as assessed by RECIST criteria

Secondary Outcomes

OS(From date of initiation of treatment to date of death due to any cause, assessed up to 2 years)
PFS(From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years)