Trials / Terminated
TerminatedNCT02122172
Afatinib in Advanced Refractory Urothelial Cancer
Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.
Detailed description
PRIMARY OBJECTIVES: I. To determine the 3-month progression free survival (PFS) rate in metastatic urothelial cancer patients receiving afatinib (afatinib dimaleate) who have progressed despite prior platinum-based chemotherapy. SECONDARY OBJECTIVES: I. To determine the overall response rate (complete response \[CR\] + partial response \[PR\]), median progression free survival, and overall survival for the same treated population. II. To determine whether tumor epidermal growth factor receptor (EGFR) and/or HER2 overexpression influences 3-month PFS in patients treated with afatinib. OUTLINE: Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.
Conditions
- Distal Urethral Cancer
- Proximal Urethral Cancer
- Recurrent Bladder Cancer
- Recurrent Urethral Cancer
- Stage III Bladder Cancer
- Stage III Urethral Cancer
- Stage IV Bladder Cancer
- Stage IV Urethral Cancer
- Ureter Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | afatinib dimaleate | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2017-09-13
- Primary completion
- 2024-04-04
- Completion
- 2024-04-04
- First posted
- 2014-04-24
- Last updated
- 2025-04-25
- Results posted
- 2025-04-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02122172. Inclusion in this directory is not an endorsement.