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NCT01938573 · ClinicalTrials.gov registry record · Phase 1

Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer

A Phase 1 study, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT01938573: Completed Phase 1 study, sponsored by University of Washington.

NCT01938573 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01938573, a Phase 1 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.

Primary Outcome

Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).

Interventions

  • DRUG Sirolimus
  • DRUG Cisplatin
  • PROCEDURE Cystectomy
  • DRUG Gemcitabine Hydrochloride

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2013-10
Est. Completion 2016-08-18
Phase Phase 1
University of Washington

1,048 total trials

What the finished NCT01938573 record still lists

NCT01938573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 4 interventions - of which Sirolimus is the first listed.

NCT01938573 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01938573 about?

NCT01938573 is a clinical study titled "Sirolimus, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Bladder Cancer". This phase I/II trial studies the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate or suppress the immune system in d...

What is the current status of trial NCT01938573?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2013-10. Estimated completion is 2016-08-18.

What interventions are being tested in trial NCT01938573?

The interventions under investigation include: Sirolimus (DRUG), Cisplatin (DRUG), Cystectomy (PROCEDURE), Gemcitabine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01938573?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01938573's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01938573, the US trial registry maintained by the National Library of Medicine. NCT01938573 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.