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NCT02122172 · ClinicalTrials.gov registry record · Phase 2

Afatinib in Advanced Refractory Urothelial Cancer

A Phase 2 study, sponsored by University of Chicago.

Terminated
Registry status
Phase 2
Development phase
32
Enrollment target

NCT02122172: Clinical Trial Phase 2 study, sponsored by University of Chicago.

NCT02122172 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02122172, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.

TERMINATED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study 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.

Primary Outcome

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated at 3 months using the Kaplan-Meier method.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG afatinib dimaleate

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2017-09-13
Est. Completion 2024-04-04
Phase Phase 2
University of Chicago

796 total trials

Why NCT02122172 stopped before completion

NCT02122172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.

NCT02122172 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02122172 about?

NCT02122172 is a clinical study titled "Afatinib in Advanced Refractory Urothelial Cancer". 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...

What is the current status of trial NCT02122172?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2017-09-13. Estimated completion is 2024-04-04.

What interventions are being tested in trial NCT02122172?

The interventions under investigation include: laboratory biomarker analysis (OTHER), afatinib dimaleate (DRUG).

Who is sponsoring clinical trial NCT02122172?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02122172's enrollment target sits among peer trials

32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02122172, the US trial registry maintained by the National Library of Medicine. NCT02122172 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.