Afatinib in Advanced Refractory Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT02122172|
Recruitment Status : Recruiting
First Posted : April 24, 2014
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: afatinib dimaleate Other: laboratory biomarker analysis||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer|
|Actual Study Start Date :||October 30, 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Treatment (afatinib)
Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: afatinib dimaleate
Other Names:Other: laboratory biomarker analysis
- Progression-free survival (PFS) [ Time Frame: 3 months ]Estimated using the Kaplan-Meier method.
- Overall response rate (CR + PR) [ Time Frame: Up to 3 years ]
- Median progression-free survival (PFS ) time [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- EGFR expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- HER2 expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Presence of tumor micro ribonucleic acids (RNAs) like miR-200 [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Epithelial to mesenchymal transition states [ Time Frame: Up to 3 years ]
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days after last administration of trial drugs ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122172
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Peter H. O'Donnell 773-702-7564 firstname.lastname@example.org|
|Principal Investigator: Peter H. O'Donnell|
|Decatur Memorial Hospital||Recruiting|
|Decatur, Illinois, United States, 62526|
|Contact: James L. Wade 217-876-6600 JLWADE3@sbcglobal.net|
|Principal Investigator: James L. Wade|
|NorthShore University Health System||Completed|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Peter O'Donnell||University of Chicago|