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NCT00419159 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
199
Enrollment target

NCT00419159: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT00419159 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00419159, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
199 participants
Enrollment target

Study Summary

To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.

Primary Outcome

RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete res

Interventions

  • DRUG Everolimus (RAD001)

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2006-12
Est. Completion 2009-03
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00419159 record still lists

NCT00419159 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).

The record links to 0 conditions, and to 1 intervention - of which Everolimus (RAD001) is the first listed.

NCT00419159 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00419159 about?

NCT00419159 is a clinical study titled "Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy". To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.

What is the current status of trial NCT00419159?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2006-12. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00419159?

The interventions under investigation include: Everolimus (RAD001) (DRUG).

Who is sponsoring clinical trial NCT00419159?

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 NCT00419159's enrollment target sits among peer trials

199 349th of 2000 higher than 1,652 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 NCT00419159, the US trial registry maintained by the National Library of Medicine. NCT00419159 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.