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

NCT05318339 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-08

No results posted yet for this study

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.

Conditions

  • Carcinoma, Transitional Cell
  • HER-2 Gene Amplification

Interventions

DRUG

Trastuzumab

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2024-03-10
Completion
2024-12-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05318339 on ClinicalTrials.gov