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Trial record 6 of 10 for:    "Clear Cell Renal Cell Carcinoma" | "Interferon alpha-2"

Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00719264
Recruitment Status : Completed
First Posted : July 21, 2008
Results First Posted : May 7, 2014
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma
Adenocarcinoma
Renal Cell
Nephroid Carcinoma
Hypernephroid
Interventions Drug: RAD001(everolimus)
Drug: interferon alfa-2a
Drug: bevacizumab
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Period Title: Overall Study
Started 182 183
Full Analysis Set 182 183
Safety Set 180 181
Completed 0 0
Not Completed 182 183
Reason Not Completed
Adverse Event             41             49
Death             13             10
Administrative Problems             6             4
Lost to Follow-up             1             1
Withdrawal by Subject             12             7
Protocol Deviation             1             3
New Cancer Therapy             4             2
Disease Progression             104             107
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN) Total
Hide Arm/Group Description Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 182 183 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 183 participants 365 participants
60.71  (10.584) 59.93  (10.272) 60.32  (10.422)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 183 participants 365 participants
Female
44
  24.2%
52
  28.4%
96
  26.3%
Male
138
  75.8%
131
  71.6%
269
  73.7%
1.Primary Outcome
Title Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Hide Description Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time Frame Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: This set consists of all randomized participants.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 182 183
Median (95% Confidence Interval)
Unit of Measure: Months
9.3
(8.1 to 11.2)
10.0
(8.3 to 12.9)
2.Secondary Outcome
Title Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Hide Description Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Time Frame Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: This set consists of all randomized participants.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 182 183
Median (95% Confidence Interval)
Unit of Measure: Months
27.1
(19.9 to 35.3)
27.1
(20.4 to 30.8)
3.Secondary Outcome
Title Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Hide Description Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time Frame Time from first participant randomized until 31Dec2011, cutoff date.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: This set consists of all randomized participants.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 182 183
Measure Type: Number
Unit of Measure: Number of participants
Complete response (CR) 0 1
Partial response (PR) 49 50
Stable disease (SD) 90 84
Progressive disease (PD) 25 26
Unknown response 18 22
Overall objective response (CR+PR) 49 51
4.Secondary Outcome
Title Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Hide Description The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Time Frame Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 49 51
Median (95% Confidence Interval)
Unit of Measure: Months
13.3
(10.7 to 16.7)
11.3 [1] 
(10.4 to NA)
[1]
The upper limit was not estimable as it is longer than the estimated time period per data cutoff (31Dec2011).
5.Secondary Outcome
Title Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Hide Description Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
Time Frame From the first participant randomized until the last patient discontinued the study treatment + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 180 181
Measure Type: Number
Unit of Measure: Participants
Adverse events (serious and non-serious) 179 180
Serious adverse events 79 76
Deaths 93 95
6.Secondary Outcome
Title Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
Hide Description The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
Time Frame Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: This set consists of all randomized participants.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 182 183
Median (95% Confidence Interval)
Unit of Measure: Months
7.4
(4.7 to 10.8)
8.0
(3.7 to 11.5)
7.Secondary Outcome
Title Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Hide Description The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
Time Frame Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: This set consists of all randomized participants.
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
Overall Number of Participants Analyzed 182 183
Median (95% Confidence Interval)
Unit of Measure: Months
Global health status/QoL
7.4
(5.3 to 12.0)
7.8
(5.6 to 10.2)
Physical functioning
8.5
(5.6 to 13.8)
9.0
(6.5 to 12.9)
8.Secondary Outcome
Title Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
Hide Description This outcome measure was assessed continuously.
Time Frame From the date of the first participant treated until the last patient discontinued the study treatment + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.
Arm/Group Title Bevacizumab, RAD001 (Everolimus)
Hide Arm/Group Description:
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks.
Overall Number of Participants Analyzed 180
Median (Full Range)
Unit of Measure: weeks
37.0
(2 to 190)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Hide Arm/Group Description Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks. Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks.
All-Cause Mortality
Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Affected / at Risk (%) Affected / at Risk (%)
Total   79/180 (43.89%)   76/181 (41.99%) 
Blood and lymphatic system disorders     
ANAEMIA  1  6/180 (3.33%)  8/181 (4.42%) 
LEUKOPENIA  1  1/180 (0.56%)  0/181 (0.00%) 
LYMPHADENOPATHY MEDIASTINAL  1  0/180 (0.00%)  1/181 (0.55%) 
THROMBOCYTOPENIA  1  2/180 (1.11%)  0/181 (0.00%) 
Cardiac disorders     
ANGINA PECTORIS  1  1/180 (0.56%)  0/181 (0.00%) 
CARDIAC ARREST  1  1/180 (0.56%)  2/181 (1.10%) 
CARDIAC FAILURE  1  3/180 (1.67%)  0/181 (0.00%) 
CARDIAC FAILURE ACUTE  1  1/180 (0.56%)  0/181 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  3/180 (1.67%)  1/181 (0.55%) 
TACHYCARDIA  1  0/180 (0.00%)  1/181 (0.55%) 
VENTRICULAR TACHYCARDIA  1  0/180 (0.00%)  1/181 (0.55%) 
Ear and labyrinth disorders     
DEAFNESS  1  0/180 (0.00%)  1/181 (0.55%) 
TINNITUS  1  1/180 (0.56%)  0/181 (0.00%) 
VERTIGO  1  0/180 (0.00%)  1/181 (0.55%) 
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  1/180 (0.56%)  1/181 (0.55%) 
ABDOMINAL PAIN  1  8/180 (4.44%)  3/181 (1.66%) 
ABDOMINAL PAIN UPPER  1  0/180 (0.00%)  2/181 (1.10%) 
ANAL FISSURE  1  1/180 (0.56%)  0/181 (0.00%) 
ANAL FISTULA  1  1/180 (0.56%)  0/181 (0.00%) 
ASCITES  1  2/180 (1.11%)  0/181 (0.00%) 
COLITIS  1  0/180 (0.00%)  2/181 (1.10%) 
DIARRHOEA  1  5/180 (2.78%)  1/181 (0.55%) 
DYSPHAGIA  1  1/180 (0.56%)  0/181 (0.00%) 
ENTERITIS  1  1/180 (0.56%)  1/181 (0.55%) 
FLATULENCE  1  0/180 (0.00%)  1/181 (0.55%) 
GASTRIC FISTULA  1  1/180 (0.56%)  0/181 (0.00%) 
GASTRIC ULCER  1  1/180 (0.56%)  1/181 (0.55%) 
GASTRIC ULCER HAEMORRHAGE  1  1/180 (0.56%)  0/181 (0.00%) 
GASTRITIS  1  0/180 (0.00%)  1/181 (0.55%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/180 (0.56%)  0/181 (0.00%) 
HAEMORRHOIDAL HAEMORRHAGE  1  0/180 (0.00%)  1/181 (0.55%) 
INTESTINAL ISCHAEMIA  1  1/180 (0.56%)  0/181 (0.00%) 
INTESTINAL OBSTRUCTION  1  3/180 (1.67%)  1/181 (0.55%) 
MOUTH HAEMORRHAGE  1  0/180 (0.00%)  1/181 (0.55%) 
NAUSEA  1  4/180 (2.22%)  2/181 (1.10%) 
PANCREATITIS  1  1/180 (0.56%)  1/181 (0.55%) 
PANCREATITIS CHRONIC  1  1/180 (0.56%)  0/181 (0.00%) 
PROCTITIS  1  1/180 (0.56%)  0/181 (0.00%) 
RECTAL HAEMORRHAGE  1  1/180 (0.56%)  0/181 (0.00%) 
RETROPERITONEUM CYST  1  1/180 (0.56%)  0/181 (0.00%) 
SIGMOIDITIS  1  1/180 (0.56%)  0/181 (0.00%) 
SMALL INTESTINAL OBSTRUCTION  1  1/180 (0.56%)  0/181 (0.00%) 
STOMATITIS  1  3/180 (1.67%)  0/181 (0.00%) 
TOOTHACHE  1  0/180 (0.00%)  1/181 (0.55%) 
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/180 (0.56%)  0/181 (0.00%) 
VOMITING  1  4/180 (2.22%)  2/181 (1.10%) 
General disorders     
ASTHENIA  1  1/180 (0.56%)  2/181 (1.10%) 
DISEASE PROGRESSION  1  1/180 (0.56%)  3/181 (1.66%) 
DRUG INEFFECTIVE  1  0/180 (0.00%)  1/181 (0.55%) 
FATIGUE  1  2/180 (1.11%)  3/181 (1.66%) 
GENERAL PHYSICAL HEALTH DETERIORATION  1  2/180 (1.11%)  4/181 (2.21%) 
GENERALISED OEDEMA  1  1/180 (0.56%)  0/181 (0.00%) 
HYPERPYREXIA  1  0/180 (0.00%)  1/181 (0.55%) 
MULTI-ORGAN FAILURE  1  0/180 (0.00%)  1/181 (0.55%) 
NON-CARDIAC CHEST PAIN  1  0/180 (0.00%)  2/181 (1.10%) 
OEDEMA PERIPHERAL  1  1/180 (0.56%)  0/181 (0.00%) 
PERFORMANCE STATUS DECREASED  1  1/180 (0.56%)  0/181 (0.00%) 
PYREXIA  1  3/180 (1.67%)  0/181 (0.00%) 
SUDDEN DEATH  1  1/180 (0.56%)  0/181 (0.00%) 
Hepatobiliary disorders     
BILE DUCT OBSTRUCTION  1  0/180 (0.00%)  1/181 (0.55%) 
CHOLECYSTITIS  1  0/180 (0.00%)  1/181 (0.55%) 
CHOLELITHIASIS  1  0/180 (0.00%)  1/181 (0.55%) 
CHOLESTASIS  1  0/180 (0.00%)  1/181 (0.55%) 
HEPATOTOXICITY  1  1/180 (0.56%)  0/181 (0.00%) 
JAUNDICE  1  1/180 (0.56%)  0/181 (0.00%) 
Infections and infestations     
ANAL ABSCESS  1  3/180 (1.67%)  0/181 (0.00%) 
BRONCHITIS  1  1/180 (0.56%)  0/181 (0.00%) 
BRONCHOPNEUMONIA  1  1/180 (0.56%)  1/181 (0.55%) 
ESCHERICHIA URINARY TRACT INFECTION  1  0/180 (0.00%)  1/181 (0.55%) 
INJECTION SITE INFECTION  1  0/180 (0.00%)  1/181 (0.55%) 
LARYNGITIS  1  0/180 (0.00%)  1/181 (0.55%) 
LUNG INFECTION  1  0/180 (0.00%)  1/181 (0.55%) 
MYELITIS  1  0/180 (0.00%)  1/181 (0.55%) 
NECROTISING FASCIITIS  1  1/180 (0.56%)  0/181 (0.00%) 
OSTEOMYELITIS  1  1/180 (0.56%)  1/181 (0.55%) 
PHARYNGITIS  1  1/180 (0.56%)  0/181 (0.00%) 
PNEUMONIA  1  6/180 (3.33%)  2/181 (1.10%) 
PYELONEPHRITIS  1  0/180 (0.00%)  1/181 (0.55%) 
RESPIRATORY TRACT INFECTION  1  2/180 (1.11%)  1/181 (0.55%) 
SEPSIS  1  4/180 (2.22%)  1/181 (0.55%) 
SEPTIC SHOCK  1  1/180 (0.56%)  0/181 (0.00%) 
SINUSITIS BACTERIAL  1  0/180 (0.00%)  1/181 (0.55%) 
TONSILLITIS  1  1/180 (0.56%)  0/181 (0.00%) 
TUBERCULOSIS  1  0/180 (0.00%)  1/181 (0.55%) 
URINARY TRACT INFECTION  1  1/180 (0.56%)  3/181 (1.66%) 
Injury, poisoning and procedural complications     
ALCOHOL POISONING  1  1/180 (0.56%)  0/181 (0.00%) 
CEMENT EMBOLISM  1  1/180 (0.56%)  0/181 (0.00%) 
CRANIOCEREBRAL INJURY  1  1/180 (0.56%)  0/181 (0.00%) 
FALL  1  0/180 (0.00%)  1/181 (0.55%) 
FEMUR FRACTURE  1  1/180 (0.56%)  0/181 (0.00%) 
FRACTURE  1  1/180 (0.56%)  0/181 (0.00%) 
HEPATIC HAEMATOMA  1  0/180 (0.00%)  1/181 (0.55%) 
INCISIONAL HERNIA  1  1/180 (0.56%)  0/181 (0.00%) 
LACERATION  1  0/180 (0.00%)  1/181 (0.55%) 
SPINAL COMPRESSION FRACTURE  1  1/180 (0.56%)  0/181 (0.00%) 
SUBDURAL HAEMATOMA  1  1/180 (0.56%)  0/181 (0.00%) 
TOXICITY TO VARIOUS AGENTS  1  1/180 (0.56%)  1/181 (0.55%) 
VASCULAR PSEUDOANEURYSM  1  0/180 (0.00%)  1/181 (0.55%) 
Investigations     
BLOOD CREATINE INCREASED  1  1/180 (0.56%)  0/181 (0.00%) 
BLOOD CREATININE INCREASED  1  3/180 (1.67%)  0/181 (0.00%) 
EJECTION FRACTION DECREASED  1  1/180 (0.56%)  0/181 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/180 (0.00%)  1/181 (0.55%) 
HAEMOGLOBIN DECREASED  1  1/180 (0.56%)  0/181 (0.00%) 
WEIGHT DECREASED  1  1/180 (0.56%)  2/181 (1.10%) 
Metabolism and nutrition disorders     
CACHEXIA  1  1/180 (0.56%)  0/181 (0.00%) 
DECREASED APPETITE  1  3/180 (1.67%)  4/181 (2.21%) 
DEHYDRATION  1  3/180 (1.67%)  3/181 (1.66%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  1/180 (0.56%)  0/181 (0.00%) 
HYPERCALCAEMIA  1  3/180 (1.67%)  1/181 (0.55%) 
HYPERGLYCAEMIA  1  1/180 (0.56%)  0/181 (0.00%) 
HYPERKALAEMIA  1  1/180 (0.56%)  1/181 (0.55%) 
HYPERVOLAEMIA  1  0/180 (0.00%)  1/181 (0.55%) 
HYPOALBUMINAEMIA  1  0/180 (0.00%)  1/181 (0.55%) 
HYPOGLYCAEMIA  1  2/180 (1.11%)  0/181 (0.00%) 
HYPOKALAEMIA  1  1/180 (0.56%)  0/181 (0.00%) 
HYPONATRAEMIA  1  3/180 (1.67%)  3/181 (1.66%) 
METABOLIC ACIDOSIS  1  1/180 (0.56%)  0/181 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/180 (0.56%)  4/181 (2.21%) 
BACK PAIN  1  1/180 (0.56%)  5/181 (2.76%) 
BONE LOSS  1  1/180 (0.56%)  0/181 (0.00%) 
BONE PAIN  1  1/180 (0.56%)  1/181 (0.55%) 
GROIN PAIN  1  1/180 (0.56%)  0/181 (0.00%) 
INTERVERTEBRAL DISC PROTRUSION  1  1/180 (0.56%)  0/181 (0.00%) 
MUSCULAR WEAKNESS  1  1/180 (0.56%)  0/181 (0.00%) 
PAIN IN EXTREMITY  1  0/180 (0.00%)  1/181 (0.55%) 
PATHOLOGICAL FRACTURE  1  0/180 (0.00%)  3/181 (1.66%) 
ROTATOR CUFF SYNDROME  1  1/180 (0.56%)  0/181 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
CANCER PAIN  1  0/180 (0.00%)  1/181 (0.55%) 
INTESTINAL ADENOCARCINOMA  1  0/180 (0.00%)  1/181 (0.55%) 
MALIGNANT NEOPLASM PROGRESSION  1  0/180 (0.00%)  1/181 (0.55%) 
METASTASES TO BONE  1  1/180 (0.56%)  0/181 (0.00%) 
PROSTATE CANCER  1  1/180 (0.56%)  0/181 (0.00%) 
Nervous system disorders     
CEREBRAL INFARCTION  1  1/180 (0.56%)  0/181 (0.00%) 
CEREBRAL ISCHAEMIA  1  0/180 (0.00%)  1/181 (0.55%) 
CEREBROVASCULAR ACCIDENT  1  0/180 (0.00%)  3/181 (1.66%) 
COMA  1  0/180 (0.00%)  1/181 (0.55%) 
CONVULSION  1  1/180 (0.56%)  1/181 (0.55%) 
DIZZINESS  1  1/180 (0.56%)  1/181 (0.55%) 
ENCEPHALOPATHY  1  0/180 (0.00%)  1/181 (0.55%) 
EPILEPSY  1  0/180 (0.00%)  2/181 (1.10%) 
HAEMORRHAGE INTRACRANIAL  1  1/180 (0.56%)  0/181 (0.00%) 
HEADACHE  1  2/180 (1.11%)  0/181 (0.00%) 
SPINAL CORD COMPRESSION  1  1/180 (0.56%)  1/181 (0.55%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/180 (0.00%)  2/181 (1.10%) 
Psychiatric disorders     
ACUTE PSYCHOSIS  1  0/180 (0.00%)  1/181 (0.55%) 
ANXIETY  1  0/180 (0.00%)  1/181 (0.55%) 
CONFUSIONAL STATE  1  0/180 (0.00%)  2/181 (1.10%) 
DELIRIUM  1  1/180 (0.56%)  0/181 (0.00%) 
DEPRESSION  1  0/180 (0.00%)  1/181 (0.55%) 
MENTAL STATUS CHANGES  1  0/180 (0.00%)  1/181 (0.55%) 
SOPOR  1  0/180 (0.00%)  1/181 (0.55%) 
Renal and urinary disorders     
BLADDER DILATATION  1  0/180 (0.00%)  1/181 (0.55%) 
NEPHROTIC SYNDROME  1  1/180 (0.56%)  1/181 (0.55%) 
OLIGURIA  1  1/180 (0.56%)  0/181 (0.00%) 
PROTEINURIA  1  1/180 (0.56%)  2/181 (1.10%) 
RENAL COLIC  1  1/180 (0.56%)  0/181 (0.00%) 
RENAL FAILURE  1  5/180 (2.78%)  1/181 (0.55%) 
RENAL FAILURE ACUTE  1  2/180 (1.11%)  0/181 (0.00%) 
RENAL IMPAIRMENT  1  0/180 (0.00%)  2/181 (1.10%) 
TUBULOINTERSTITIAL NEPHRITIS  1  1/180 (0.56%)  0/181 (0.00%) 
URINARY RETENTION  1  1/180 (0.56%)  0/181 (0.00%) 
Reproductive system and breast disorders     
MENORRHAGIA  1  1/180 (0.56%)  0/181 (0.00%) 
TESTICULAR PAIN  1  1/180 (0.56%)  0/181 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ACUTE PULMONARY OEDEMA  1  1/180 (0.56%)  0/181 (0.00%) 
ATELECTASIS  1  0/180 (0.00%)  1/181 (0.55%) 
BRONCHOSPASM  1  1/180 (0.56%)  0/181 (0.00%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  2/180 (1.11%)  0/181 (0.00%) 
COUGH  1  1/180 (0.56%)  0/181 (0.00%) 
DYSPNOEA  1  6/180 (3.33%)  3/181 (1.66%) 
DYSPNOEA EXERTIONAL  1  0/180 (0.00%)  1/181 (0.55%) 
EMPHYSEMA  1  0/180 (0.00%)  1/181 (0.55%) 
EPISTAXIS  1  5/180 (2.78%)  0/181 (0.00%) 
HAEMOPTYSIS  1  2/180 (1.11%)  2/181 (1.10%) 
PLEURAL EFFUSION  1  3/180 (1.67%)  2/181 (1.10%) 
PNEUMONIA ASPIRATION  1  1/180 (0.56%)  0/181 (0.00%) 
PNEUMONITIS  1  1/180 (0.56%)  0/181 (0.00%) 
PULMONARY EMBOLISM  1  1/180 (0.56%)  2/181 (1.10%) 
PULMONARY OEDEMA  1  1/180 (0.56%)  1/181 (0.55%) 
RESPIRATORY FAILURE  1  1/180 (0.56%)  0/181 (0.00%) 
SLEEP APNOEA SYNDROME  1  1/180 (0.56%)  0/181 (0.00%) 
Vascular disorders     
ACCELERATED HYPERTENSION  1  0/180 (0.00%)  1/181 (0.55%) 
CIRCULATORY COLLAPSE  1  1/180 (0.56%)  0/181 (0.00%) 
HYPERTENSION  1  4/180 (2.22%)  3/181 (1.66%) 
HYPERTENSIVE CRISIS  1  2/180 (1.11%)  2/181 (1.10%) 
HYPOTENSION  1  1/180 (0.56%)  0/181 (0.00%) 
HYPOVOLAEMIC SHOCK  1  1/180 (0.56%)  0/181 (0.00%) 
THROMBOSIS  1  0/180 (0.00%)  1/181 (0.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab, RAD001 (Everolimus) Bevacizumab, Interferon Alfa-2a (IFN)
Affected / at Risk (%) Affected / at Risk (%)
Total   173/180 (96.11%)   179/181 (98.90%) 
Blood and lymphatic system disorders     
ANAEMIA  1  35/180 (19.44%)  35/181 (19.34%) 
LEUKOPENIA  1  4/180 (2.22%)  12/181 (6.63%) 
LYMPHOPENIA  1  4/180 (2.22%)  11/181 (6.08%) 
NEUTROPENIA  1  7/180 (3.89%)  21/181 (11.60%) 
THROMBOCYTOPENIA  1  16/180 (8.89%)  29/181 (16.02%) 
Cardiac disorders     
TACHYCARDIA  1  9/180 (5.00%)  2/181 (1.10%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  18/180 (10.00%)  19/181 (10.50%) 
ABDOMINAL PAIN UPPER  1  10/180 (5.56%)  9/181 (4.97%) 
CONSTIPATION  1  30/180 (16.67%)  26/181 (14.36%) 
DIARRHOEA  1  71/180 (39.44%)  47/181 (25.97%) 
DRY MOUTH  1  3/180 (1.67%)  11/181 (6.08%) 
DYSPEPSIA  1  8/180 (4.44%)  11/181 (6.08%) 
GINGIVAL BLEEDING  1  3/180 (1.67%)  11/181 (6.08%) 
MOUTH ULCERATION  1  13/180 (7.22%)  3/181 (1.66%) 
NAUSEA  1  38/180 (21.11%)  50/181 (27.62%) 
STOMATITIS  1  111/180 (61.67%)  42/181 (23.20%) 
TOOTHACHE  1  16/180 (8.89%)  12/181 (6.63%) 
VOMITING  1  25/180 (13.89%)  26/181 (14.36%) 
General disorders     
ASTHENIA  1  39/180 (21.67%)  62/181 (34.25%) 
CHILLS  1  4/180 (2.22%)  21/181 (11.60%) 
FATIGUE  1  57/180 (31.67%)  75/181 (41.44%) 
INFLUENZA LIKE ILLNESS  1  5/180 (2.78%)  32/181 (17.68%) 
MALAISE  1  2/180 (1.11%)  11/181 (6.08%) 
OEDEMA PERIPHERAL  1  44/180 (24.44%)  18/181 (9.94%) 
PYREXIA  1  24/180 (13.33%)  63/181 (34.81%) 
Infections and infestations     
GINGIVITIS  1  10/180 (5.56%)  7/181 (3.87%) 
INFLUENZA  1  10/180 (5.56%)  5/181 (2.76%) 
SINUSITIS  1  10/180 (5.56%)  6/181 (3.31%) 
UPPER RESPIRATORY TRACT INFECTION  1  18/180 (10.00%)  7/181 (3.87%) 
URINARY TRACT INFECTION  1  16/180 (8.89%)  16/181 (8.84%) 
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  9/180 (5.00%)  4/181 (2.21%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  10/180 (5.56%)  5/181 (2.76%) 
BLOOD CREATININE INCREASED  1  20/180 (11.11%)  7/181 (3.87%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  10/180 (5.56%)  13/181 (7.18%) 
WEIGHT DECREASED  1  51/180 (28.33%)  58/181 (32.04%) 
Metabolism and nutrition disorders     
DECREASED APPETITE  1  48/180 (26.67%)  80/181 (44.20%) 
HYPERCHOLESTEROLAEMIA  1  40/180 (22.22%)  8/181 (4.42%) 
HYPERGLYCAEMIA  1  18/180 (10.00%)  5/181 (2.76%) 
HYPERKALAEMIA  1  5/180 (2.78%)  11/181 (6.08%) 
HYPERTRIGLYCERIDAEMIA  1  24/180 (13.33%)  17/181 (9.39%) 
HYPERURICAEMIA  1  3/180 (1.67%)  14/181 (7.73%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  33/180 (18.33%)  37/181 (20.44%) 
BACK PAIN  1  22/180 (12.22%)  26/181 (14.36%) 
BONE PAIN  1  8/180 (4.44%)  10/181 (5.52%) 
MUSCULOSKELETAL CHEST PAIN  1  9/180 (5.00%)  11/181 (6.08%) 
MYALGIA  1  11/180 (6.11%)  34/181 (18.78%) 
PAIN IN EXTREMITY  1  25/180 (13.89%)  17/181 (9.39%) 
Nervous system disorders     
DIZZINESS  1  11/180 (6.11%)  12/181 (6.63%) 
DYSGEUSIA  1  21/180 (11.67%)  7/181 (3.87%) 
HEADACHE  1  36/180 (20.00%)  38/181 (20.99%) 
Psychiatric disorders     
DEPRESSION  1  8/180 (4.44%)  25/181 (13.81%) 
INSOMNIA  1  23/180 (12.78%)  25/181 (13.81%) 
Renal and urinary disorders     
DYSURIA  1  10/180 (5.56%)  10/181 (5.52%) 
PROTEINURIA  1  90/180 (50.00%)  68/181 (37.57%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  54/180 (30.00%)  34/181 (18.78%) 
DYSPHONIA  1  11/180 (6.11%)  9/181 (4.97%) 
DYSPNOEA  1  28/180 (15.56%)  32/181 (17.68%) 
EPISTAXIS  1  62/180 (34.44%)  38/181 (20.99%) 
OROPHARYNGEAL PAIN  1  18/180 (10.00%)  7/181 (3.87%) 
PNEUMONITIS  1  12/180 (6.67%)  1/181 (0.55%) 
RHINORRHOEA  1  13/180 (7.22%)  9/181 (4.97%) 
Skin and subcutaneous tissue disorders     
DERMATITIS  1  13/180 (7.22%)  2/181 (1.10%) 
DERMATITIS ACNEIFORM  1  9/180 (5.00%)  1/181 (0.55%) 
DRY SKIN  1  22/180 (12.22%)  16/181 (8.84%) 
PRURITUS  1  31/180 (17.22%)  22/181 (12.15%) 
RASH  1  42/180 (23.33%)  20/181 (11.05%) 
Vascular disorders     
HYPERTENSION  1  67/180 (37.22%)  39/181 (21.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00719264     History of Changes
Other Study ID Numbers: CRAD001L2201
2008-000077-38 ( EudraCT Number )
First Submitted: July 15, 2008
First Posted: July 21, 2008
Results First Submitted: April 4, 2014
Results First Posted: May 7, 2014
Last Update Posted: March 20, 2017