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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: Completed Phase 2 study of Non-Small-Cell Lung Carcinoma, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2005-07 |
| Phase | Phase 2 |
What the finished NCT00124280 record still lists
NCT00124280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 233-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00124280's enrollment target sits among peer trials
85 18th of 30 higher than 13 of 30 other Non-Small-Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small-Cell Lung Carcinoma 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.
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