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A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma

Primary Purpose

Carcinoma, Transitional Cell, HER-2 Gene Amplification

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Trastuzumab

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis

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
May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
There are other serious diseases that the researchers believe patients cannot be included in the study

Sites / Locations

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab + Pyrotinib

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR

Objective response rate as assessed by RECIST criteria

Secondary Outcome Measures

Overall survival

PFS

Progression free survival

Full Information

NCT ID

NCT05318339

First Posted

March 31, 2022

Last Updated

March 31, 2022

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05318339

Brief Title

A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

March 10, 2024 (Anticipated)

Study Completion Date

December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Transitional Cell, HER-2 Gene Amplification

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab + Pyrotinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Other Intervention Name(s)

Pyrotinib

Intervention Description

A loading dose of trastuzumab 8mg/kg IV over 90 minutes will be administrated on day 1 of week 1. For all subsequent doses, trastuzumab 6mg/kg IV over 30 minutes will be administrated every three weeks. Pyrotinib 400mg PO daily will be administrated at the same time.

Primary Outcome Measure Information:

Title

ORR

Description

Objective response rate as assessed by RECIST criteria

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Description

Overall survival

Time Frame

From date of initiation of treatment to date of death due to any cause, assessed up to 2 years

Title

PFS

Description

Progression free survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: Blood routine: hemoglobin ≥80g/L, neutrophil ≥1.5×10^9/L, platelet ≥75×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL, ALT≤5×UNL and AST≤5×UNL for patients with liver metastasis 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 May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results There are other serious diseases that the researchers believe patients cannot be included in the study

Facility Information:

Facility Name

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aiping Zhou, MD

Phone

+86 13691161998

zhouap1825@126.com

12. IPD Sharing Statement

Learn more about this trial

A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma

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