Afatinib in Advanced Refractory Urothelial Cancer
-
- STATUS
- Recruiting
-
- End date
- Jun 12, 2023
-
- participants needed
- 95
-
- sponsor
- University of Chicago
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.
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.
Details
| Condition | Stage IV Bladder Cancer, urinary tract neoplasm, Proximal Urethral Cancer, Metastatic Bladder Cancer, Metastatic Bladder Carcinoma, Stage III Bladder Cancer, Stage IV Urethral Cancer, Malignant neoplasm of ureter, Recurrent Urethral Cancer, Stage III Urethral Cancer, Distal Urethral Cancer, Urologic Cancer, Recurrent Bladder Cancer |
|---|---|
| Treatment | laboratory biomarker analysis, afatinib dimaleate |
| Clinical Study Identifier | NCT02122172 |
| Sponsor | University of Chicago |
| Last Modified on | 7 October 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer