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NCT01035229 · ClinicalTrials.gov registry record · Phase 3

Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
546
Enrollment target

NCT01035229 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 546 participants.

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The verdict

NCT01035229, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
546 participants
Enrollment target

Study Summary

The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

Interventions

  • DRUG Everolimus
  • OTHER Best Supportive Care (BSC)
  • DRUG Everolimus Placebo

Trial Details

FieldValue
Enrollment Target 546 participants
Start Date 2010-04
Est. Completion 2013-10
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01035229

The ClinicalTrials.gov registry entry for NCT01035229 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 546 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Everolimus is the first listed.

NCT01035229 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01035229 about?

NCT01035229 is a clinical study titled "Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.". The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib.

What is the current status of trial NCT01035229?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 546 participants. The study started on 2010-04. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01035229?

The interventions under investigation include: Everolimus (DRUG), Best Supportive Care (BSC) (OTHER), Everolimus Placebo (DRUG).

Who is sponsoring clinical trial NCT01035229?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 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, or report a data error.