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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID: NCT00788060
Run by: Daniel George, MD
People needed: 5
Starts: 2008-10-01
Expected to finish: 2012-12-01
Last updated by the study team: 2015-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients will be eligible for inclusion in this study only if all of the following criteria apply:
Patients must have histologically confirmed diagnosis of RCC.
Patients must have undergone a nephrectomy
Clinical or radiographic evidence of metastatic disease.
A minimum of 4 weeks from full field radiation therapy, surgery, chemotherapy or other investigational agent. Treatment may begin one week following limited field radiation therapy.
Subjects who have received prior limited field radiotherapy, biologic/immunotherapy or surgery must have a documented recovery period > 2 weeks
Patients must have normal organ and marrow function as defined below:
hemoglobin > 9.0g/dL absolute neutrophil count > 1,500/μl platelets > 100,000/μl total bilirubin < 1.5 X upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) < 2.5 X ULN creatinine < 1.5 X ULN (or 24 hour measured creatinine clearance > 40 mL/min) total fasting cholesterol < 350 total triglycerides < 300
Age > 18 years.
ECOG score of 0-2 (See Appendix 11.1).
For patients with diabetes a Hgb A1C of ≤ 8
Subject agrees to use a medically acceptable form of birth control during and for at least 3 months after completion of the study treatment, if he/she is sexually active
Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to treatment
Ability to swallow and retain oral medication.
Ability to understand and the willingness to sign a written informed consent document.
Written informed consent obtained according to local guidelines

You may not qualify if…

A patient will not be eligible for inclusion in this study if any of the following criteria apply:
History of solid organ or stem cell transplantation. Also, no current use of chronic immunosuppressive therapy is allowed.
Patients with active brain metastases (or history of brain metastases) should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of HIV, hepatitis B, or hepatitis C infection.
Patients who have received investigational, biologic, hormonal (other than ADT), immunotherapy, or chemotherapy less than 4 weeks prior to entry on this study or have not recovered from the toxic effects of such therapy.
Patients who have experienced severe trauma or undergone major surgery within 4 weeks prior to entry on this study or have not recovered to grade 1 or less may not participate.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring antifungal, antibiotic or antiviral therapy), symptomatic congestive heart failure (NYHC II or greater), unstable angina pectoris, cardiac arrhythmia (uncontrolled SVT or any VT), uncontrolled diabetes or psychiatric illness/social situations that would limit compliance with study requirements.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
Patients who have received prior treatment with an mTOR inhibitor.
Patients who have received prior treatment with Sunitinib are not eligible to participate in this study.

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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