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Afatinib in Advanced Refractory Urothelial Cancer

NCT02122172 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-04-25

Study results available
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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.

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

DRUG

afatinib dimaleate

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Chicago

    lead OTHER

Principal Investigators

  • Peter O'Donnell · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2024-04-04
Completion
2024-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02122172 on ClinicalTrials.gov