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NCT00788060 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma, sponsored by Daniel George, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT00788060 is a Phase 1 study of Renal Cell Carcinoma that has completed, run by Daniel George, MD. The registered enrollment target is 5 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00788060, a Phase 1 study of Renal Cell Carcinoma, has completed, sponsored by Daniel George, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with dose limiting toxicity (DLT) determined by Cycle 2 Day 0.
Conditions Studied
Interventions
- DRUG Everolimus (RAD001)
- DRUG Sunitinib (Sutent)
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00788060
The ClinicalTrials.gov registry entry for NCT00788060 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (98% lower). The listed sponsor is Daniel George, MD, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus (RAD001) is the first listed.
NCT00788060 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00788060 about?
NCT00788060 is a clinical study titled "A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma". This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation portion, patients will be treat...
What is the current status of trial NCT00788060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2008-10. Estimated completion is 2012-12.
What conditions does trial NCT00788060 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT00788060?
The interventions under investigation include: Everolimus (RAD001) (DRUG), Sunitinib (Sutent) (DRUG).
Who is sponsoring clinical trial NCT00788060?
This trial is sponsored by Daniel George, MD, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00788060 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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