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NCT02541903 · ClinicalTrials.gov registry record · Phase 2

Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Terminated
Registry status
Phase 2
Development phase
8
Enrollment target

NCT02541903: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT02541903 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02541903, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study Summary

Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.

Primary Outcome

Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Interventions

  • DRUG Gilotrif

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2015-10
Est. Completion 2020-04
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

Why NCT02541903 stopped before completion

NCT02541903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Gilotrif is the first listed.

NCT02541903 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02541903 about?

NCT02541903 is a clinical study titled "Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma". Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients wi...

What is the current status of trial NCT02541903?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2015-10. Estimated completion is 2020-04.

What interventions are being tested in trial NCT02541903?

The interventions under investigation include: Gilotrif (DRUG).

Who is sponsoring clinical trial NCT02541903?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02541903's enrollment target sits among peer trials

8 1990th of 2000 higher than 5 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 NCT02541903, the US trial registry maintained by the National Library of Medicine. NCT02541903 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.