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NCT01259063 · ClinicalTrials.gov registry record · Phase 1

RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target

NCT01259063: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01259063 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01259063, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target

Study Summary

The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.

Interventions

  • DRUG Everolimus and Intravesical Gemcitabine

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2010-12
Est. Completion 2017-06
Phase Phase 1

Sponsor

Memorial Sloan Kettering Cancer Center

1,884 total trials

What the Registry Record Tells You About NCT01259063

The ClinicalTrials.gov registry entry for NCT01259063 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.

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

NCT01259063 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01259063 about?

NCT01259063 is a clinical study titled "RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder". The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II p...

What is the current status of trial NCT01259063?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2010-12. Estimated completion is 2017-06.

What interventions are being tested in trial NCT01259063?

The interventions under investigation include: Everolimus and Intravesical Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT01259063?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.