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NCT01482156 · ClinicalTrials.gov registry record · Phase 1

Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target

NCT01482156: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT01482156 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01482156, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

Study Summary

Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer

Primary Outcome

The maximum tolerated dose (MTD) and the dose limiting toxicities during the first cycle of treatment

Interventions

  • DRUG RAD001 + BEZ235

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2012-01
Est. Completion 2015-02
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01482156 record still lists

NCT01482156 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 1 intervention - of which RAD001 + BEZ235 is the first listed.

NCT01482156 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01482156 about?

NCT01482156 is a clinical study titled "Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors". Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BE...

What is the current status of trial NCT01482156?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2012-01. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01482156?

The interventions under investigation include: RAD001 + BEZ235 (DRUG).

Who is sponsoring clinical trial NCT01482156?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01482156's enrollment target sits among peer trials

46 1058th of 2000 higher than 935 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 NCT01482156, the US trial registry maintained by the National Library of Medicine. NCT01482156 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.