Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma (RECORD-3)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: April 24, 2009
Last updated: May 15, 2013
Last verified: May 2013
This study will assess the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.
Renal Cell Carcinoma
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.
Primary Outcome Measures:
- To assess if Progression Free Survival (PFS) after first-line of treatment in patients who receive RAD001 will be non-inferior to the PFS of patients who receive sunitinib after first-line treatment. [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the second Progression Free Survival (PFS) after the second-line of treatment in patients who receive RAD001 followed by sunitinib versus the second PFS after the second-line of treatment in patients who receive sunitinib followed by RAD001. [ Time Frame: 6 - 9 months ] [ Designated as safety issue: No ]
- To compare the safety profile of RAD001 versus sunitinib as first-line and overall for both the first-line and second-line. [ Time Frame: 6 - 16 months ] [ Designated as safety issue: Yes ]
- To assess the patient reported outcomes (PRO) in disease related symptoms and overall quality of life during each line of treatment. [ Time Frame: 6 - 16 months ] [ Designated as safety issue: No ]
- To estimate the objective response rate and duration of response differences during each line of treatment. [ Time Frame: 6 - 16 months ] [ Designated as safety issue: No ]
- To compare the overall survival rates during each line of treatment. [ Time Frame: 6 - 36 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Experimental: everolimus, sunitinib
Active Comparator: sunitinib, everolimus
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with advanced renal cell carcinoma.
- Patients with at least one measurable lesion.
- Patients with a Karnofsky Performance Status ≥70%.
- Adequate bone marrow function.
- Adequate liver function.
- Adequate renal function.
- Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN)
- Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study medication. Adequate contraception must be used while on study.
- Less than 4 weeks post-major surgery
- Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start).
- Patients in need for major surgical procedure during the course of the study
- Patients with a serious non-healing wound, ulcer, or bone fracture
- Patients with a history of seizure(s) not controlled with standard medical therapy
- Patients who have received prior systemic treatment for their metastatic RCC
- Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus) or VEGF inhibitors. Note: History of adjuvant immunotherapy, vaccines or adjuvant sorafenib following localized surgical nephrectomy is acceptable.
- Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients
- Patients with a known hypersensitivity to sunitinib or its excipients
Untreated central nervous system (CNS) metastases. Note: Subjects who have previously-treated CNS metastases (surgery plus or minus radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
- Are asymptomatic and,
- have had no evidence of active CNS metastases for ≥ 6 months prior to enrollment and,
- have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC)
Clinically significant gastrointestinal abnormalities including, but not limited to:
- Malabsorption syndrome
- Major resection of the stomach or small bowel that could affect the absorption of study drug
- Active peptic ulcer disease
- Inflammatory bowel disease
- Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥150mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]
- Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent
- Patients with a known history of HIV seropositivity.
- Patients with active bleeding.
Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study such as:
- Cardiac angioplasty or stenting, unstable angina pectoris, symptomatic peripheral vascular disease, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents ≤ 6 months before study treatment start.
- Prolongation of corrected QT interval (QTc) > 500 milliseconds (msecs).
- Severally impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air.
- Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
- Any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study.
- Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
- History of cerebrovascular accident (CVA) including transient ischemic attack (TIA).
- History of pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
- Patients who have a history of another primary malignancy and off treatment for ≤ 3 years
- Female patients of child-bearing potential who are not using adequate birth control methods, or who are pregnant or breast feeding.
- Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
- Patients unwilling or unable to comply with the protocol.
Other protocol-defined inclusion/exclusion criteria may apply
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903175
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 24, 2009
||May 15, 2013
||United States: Food and Drug Administration
Brazil: Ministry of Health
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health
Keywords provided by Novartis:
renal cell carcinoma
metastatic renal cell cancer
advanced kidney cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Physiological Effects of Drugs
Angiogenesis Modulating Agents