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NCT00719264 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
A Phase 2 study of Carcinoma and Adenocarcinoma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 365
- Enrollment target
- 20
- Study locations
NCT00719264: Completed Phase 2 study of Carcinoma and Adenocarcinoma, sponsored by Novartis Pharmaceuticals.
NCT00719264 is a Phase 2 study of Carcinoma and Adenocarcinoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 365 participants, above the 242-participant average among 29 other Carcinoma trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719264, a Phase 2 study of Carcinoma and Adenocarcinoma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 365 participants
- Enrollment target
- 20
- Study locations
Study Summary
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.
Primary Outcome
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of th
Conditions Studied
Interventions
- DRUG bevacizumab
- DRUG RAD001(everolimus)
- DRUG interferon alfa-2a
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Charleroi
- Novartis Investigative Site - Kortrijk
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Liège
California
- City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3) - Duarte
- USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 - Los Angeles
- University of California at Los Angeles Dept. of Hem/Oncology - Los Angeles
Rio Grande do Sul
- Novartis Investigative Site - Porto Alegre
- Novartis Investigative Site - Porto Alegre
São Paulo
- Novartis Investigative Site - Ribeirão Preto
- Novartis Investigative Site - Santo André
Arkansas
- Highlands Oncology Group Dept of Highlands Oncology Grp - Fayetteville
Michigan
- Karmanos Cancer Institute Dept.of KarmanosCancerInst (5) - Detroit
Nevada
- Nevada Cancer Institute Dept. of Nevada Cancer (3) - Las Vegas
Pennsylvania
- St. Luke's Hospital and Health Network St. Luke's Cancer Network - Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2008-11-12 |
| Est. Completion | 2013-04-15 |
| Phase | Phase 2 |
What the finished NCT00719264 record still lists
NCT00719264 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, above the 242-participant average among 29 other Carcinoma trials with a reported enrollment target (51% higher).
The record links to 5 conditions, with Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which bevacizumab is the first listed.
NCT00719264 names 20 study sites across 11 states, led by Other, California, Rio Grande do Sul.
Frequently Asked Questions
What is clinical trial NCT00719264 about?
NCT00719264 is a clinical study titled "Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer". To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.
What is the current status of trial NCT00719264?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 365 participants. The study started on 2008-11-12. Estimated completion is 2013-04-15.
What conditions does trial NCT00719264 study?
This clinical trial studies the following conditions: Carcinoma, Adenocarcinoma, Renal Cell, Nephroid Carcinoma, Hypernephroid.
What interventions are being tested in trial NCT00719264?
The interventions under investigation include: bevacizumab (DRUG), RAD001(everolimus) (DRUG), interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00719264?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00719264 being conducted?
This trial has 20 study locations across Arkansas, California, Michigan, Nevada, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00719264's enrollment target sits among peer trials
365 7th of 29 higher than 22 of 29 other Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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