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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: Completed Phase 1 study of Renal Cell Carcinoma, sponsored by Daniel George, MD.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 5 participants
Start Date 2008-10
Est. Completion 2012-12
Phase Phase 1
Daniel George, MD

6 total trials

What the finished NCT00788060 record still lists

NCT00788060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00788060's enrollment target sits among peer trials

5 121st of 121 the lowest of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00788060, the US trial registry maintained by the National Library of Medicine. NCT00788060 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.