Trials / Unknown
UnknownNCT05318339
A Study of Trastuzumab and Pyrotinib in HER2 Positive Locally Advanced or Metastatic Urothelial Carcinoma
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-03-10
- Primary completion
- 2024-03-10
- Completion
- 2024-12-10
- First posted
- 2022-04-08
- Last updated
- 2022-04-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05318339. Inclusion in this directory is not an endorsement.