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Everolimus Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
This study is ongoing, but not recruiting participants.

First Received on December 11, 2006.   Last Updated on February 3, 2011   History of Changes
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00410124
  Purpose

To assess whether daily treatment with everolimus can slow the growth and spread of metastatic carcinoma of the kidney. The safety of everolimus will also be studied in this trial.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: everolimus
Drug: Everolimus
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of Everolimus 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progressive Free Survival (PFS) assessed radiologically [ Time Frame: every 8 weeks during the 1st year, then; every 12 weeks during the 2nd year up to 2 years after the last patient randomized ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) assessed by the monthly overall survival assessments (Survival CRFs) [ Time Frame: assessed every month up to 2 years after the last patient was randomized into the study from the date of randomization to the time of death ] [ Designated as safety issue: No ]
  • tumor response rates assessed by tumor assessments via CT scans or MRIs of chest, abdomen and pelvis and/or physical examination [ Time Frame: every 8 weeks from the first dose of RAD001 or Matching placebo ] [ Designated as safety issue: No ]
  • efficacy of everolimus on disease-related symptoms assessed by FKSI questionnaire [ Time Frame: administered on Day 1 of every treatment Cycle and at discontinuation from the study drug from randomization to definitive deteriorative of the FKSI-DRS score ] [ Designated as safety issue: No ]
  • The patient's overall quality of life assessed by EORTC-QLQ-C30 [ Time Frame: administered on Day 1 of every treatment Cycle and at discontinuation from study treatment from randomization to definitive deterioration of the physical functioning (PF) scale score of the EORTC QLQ-C30 ] [ Designated as safety issue: No ]
  • Safety assessed by pulmonary function tests, vital signs, chest x-rays, laboratory assessments [ Time Frame: routinely performed at every cycle or as necessary and up to 28 days after the end of study treatment ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: October 2006
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus + Best Supportive Care Drug: everolimus Drug: Everolimus
Other Name: RAD001
Placebo Comparator: Placebo + Best Supportive Care Drug: everolimus Drug: Everolimus
Other Name: RAD001

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable).
  • 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 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 everolimus 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 sexes.
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410124

  Show 31 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00410124     History of Changes
Other Study ID Numbers: CRAD001C2240
Study First Received: December 11, 2006
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
advanced kidney cancer
everolimus
kidney cancer
oral therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012