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A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma

NCT00788060 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-02-16

No results posted yet for this 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

Interventions

DRUG

Everolimus (RAD001)

5mg per day, continuously

DRUG

Sunitinib (Sutent)

37.5 mg per day, 14 days on, 7 day break

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Daniel George, MD

    lead OTHER

Principal Investigators

  • Daniel J. George, M.D. · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00788060 on ClinicalTrials.gov