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NCT00124280 · ClinicalTrials.gov registry record · Phase 2

Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
85
Enrollment target
2
Study locations

NCT00124280 is a Phase 2 study of Non-Small-Cell Lung Carcinoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 85 participants, below the 233-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (64% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00124280, a Phase 2 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
85 participants
Enrollment target
2
Study locations

Study Summary

This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib, is based on following: * The medical need for the better therapy for advanced NSCLC and limited efficacy of the currently available therapy in advanced NSCLC. * Postulated association of relevant cell-signaling pathways targeted by everolimus with different aspects of oncogenesis, disease progression, and response/resistance to treatment. * Effectiveness of everolimus and rapamycin in preclinical models of lung cancer * Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced NSCLC. There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus, may be one of the key changes accounting for different aspects of oncogenesis, disease progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes to logically manipulate the cell's regulatory pathways to enable control of tumor growth.

Conditions Studied

Non-Small-Cell Lung Carcinoma

Interventions

  • DRUG RAD001

Study Locations (2)

Nevada

  • Nevada Cancer Institute - Las Vegas

Texas

  • MD Anderson Cancer Center, Department of Thoracic /Head and Neck Medical Oncology - Houston

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2005-07
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT00124280

The ClinicalTrials.gov registry entry for NCT00124280 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (64% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which RAD001 is the first listed.

NCT00124280 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Nevada, Texas.

Frequently Asked Questions

What is clinical trial NCT00124280 about?

NCT00124280 is a clinical study titled "Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)". This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib, is based on following: * The...

What is the current status of trial NCT00124280?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2005-07.

What conditions does trial NCT00124280 study?

This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.

What interventions are being tested in trial NCT00124280?

The interventions under investigation include: RAD001 (DRUG).

Who is sponsoring clinical trial NCT00124280?

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

Where is trial NCT00124280 being conducted?

This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.