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A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

Phase 3
18 Years
85 Years
Not Enrolling
Metastatic Renal Cell Carcinoma

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

Inclusion Criteria:

- Patients with metastatic carcinoma and with histological or cytological confirmation
of clear cell RCC (tissue from the original diagnosis of renal cell cancer is

- The date of progression on sunitinib and/or sorafenib must be within 6 months.

- Patients may have received one or both agents

- Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors
(i.e., bevacizumab) are permitted.

- Prior vaccine therapy in the adjuvant setting is permitted.

- Patients with at least one measurable lesion at baseline as per the Response
evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as
determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).

- Patients with a Karnofsky Performance Status ≥70%.

- Adequate bone marrow, liver and renal function.

- Patients with a life expectancy ≥ 3 months.

- Women of childbearing potential must have had a negative serum or urine pregnancy
test 48 hours prior to the administration of the first study treatment.

- Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

- Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who
have received these within 4 weeks of study entry

- Patients who have previously received mTOR inhibitors.

- Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus,
temsirolimus) or to its excipients.

- Patients with untreated CNS metastases or who are neurologically unstable despite
treatment of the CNS metastases. (Patients with treated CNS metastases, who are
neurologically stable off of corticosteroids, are eligible to enter study).

- Patients receiving chronic treatment with corticosteroids or another
immunosuppressive agent

- Patients with a known history of HIV seropositivity.

- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
(except low dose coumadin)

- Patients who have any severe and/or uncontrolled medical conditions

- Patients who have a history of another primary malignancy ≤ 3 years, with the
exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods. If barrier
contraceptives are being used, these must be continued throughout the trial by both

- Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to randomization

- Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC

Outcome Description:

Progression Free survival is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary statistical analysis of PFS was based on central radiological assessments using a one-sided stratified log-rank test. Radiological assessments: every 8 weeks (+/-1 week) during the first year and every 12 weeks (+/- 1 week) during the second year and thereafter and at the end of the study. Kaplan-Meier methodology was used to estimate the median PFS for each treatment group.

Outcome Time Frame:

Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

October 2011

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • advanced kidney cancer
  • everolimus
  • kidney cancer
  • oral therapy
  • Carcinoma
  • Carcinoma, Renal Cell



Novartis Investigative SiteSouthfield, Michigan  48075
Novartis Investigative SitePortland, Oregon  97239
Novartis Investigative SiteSpokane, Washington  99202
Novartis Investigative SitePhiladelphia, Pennsylvania  19111-2497
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteSt. Louis, Missouri  63110
Novartis Investigative SiteBuffalo, New York  14263
Novartis Investigative SiteDurham, North Carolina  27710
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteBeech Grove, Indiana  46107
Novartis Investigative SiteLouisville, Kentucky  40202
Novartis Investigative SiteBaltimore, Maryland  21201
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteDallas, Texas  75235-9179
Novartis Investigative SiteFayetteville, Arkansas  72703
Novartis Investigative SiteLas Vegas, Nevada  89135
Novartis Investigative SiteMorgantown, West Virginia  26506