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RAPTOR: RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Tumors Program in Europe (MACS0460)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688753
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : November 26, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma
Renal Cell
Non Clear Cell Renal Carcinoma
Papillary Cell Renal Carcinoma
Adenocarcinoma
Intervention Drug: RAD001
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RAD001
Hide Arm/Group Description two 5 mg tablets orally, once daily at the same time every day immediately after a meal
Period Title: Overall Study
Started 92
Completed 0
Not Completed 92
Reason Not Completed
Disease progression             55
Missing             1
Death             9
Withdrawal by Subject             3
Adverse Event             20
Protocol Violation             1
Lost to Follow-up             3
Arm/Group Title RAD001 10 mg
Hide Arm/Group Description two 5 mg tablets of everolimus orally, once daily
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
0
   0.0%
Between 18 and 65 years
76
  82.6%
>=65 years
16
  17.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
59.9  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
20
  21.7%
Male
72
  78.3%
1.Primary Outcome
Title To Evaluate Efficacy of RAD001 as Monotherapy for the Treatment of Papillary Renal Cancer. Efficacy is Defined as the Percentage of Patients Progression-free at 6 Months.
Hide Description PFSR at 6 months based on central review
Time Frame 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
PP, PPFF, ITT
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: % participants
(PPFF Set, N=44)
34.1
(24.5 to 44.8)
(PPSet, N=66)
33.3
(25.6 to 41.8)
(ITT Set, N=86)
32.6
(25.9 to 39.9)
2.Secondary Outcome
Title Disease Control Rate (SD + PR + CR)
Hide Description DCR was defined as the proportion of patients with a best overall response of CR, PR or SD and ORR as the percentage of patients with CR or PR
Time Frame 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
PP,ITT
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: % Participants
PP set
65.2
(54.4 to 74.9)
ITT set
65.1
(55.8 to 73.6)
3.Secondary Outcome
Title Objective Response Rate
Hide Description ORR is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. Response duration usually is measured from the time of initial response until documented tumor progression
Time Frame End of trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: % participants
PP Set
1.5
(0.1 to 7.0)
ITT Set
1.2
(0.1 to 5.4)
4.Secondary Outcome
Title Duration of Response
Hide Description The DOR analysis applied only to patients whose overall response was CR or PR and was defined as the time from onset of response (CR/PR) to progression or death from any cause.
Time Frame End of trial
Hide Outcome Measure Data
Hide Analysis Population Description
In the final analysis, for central review, the DOR could not be calculated as only 1 patient in the PP and ITT sets met the criteria
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Median (95% Confidence Interval)
Unit of Measure: days
local review PP set
169
(64 to 169)
local review ITT set
226
(64 to 928)
5.Secondary Outcome
Title Median Progression Free Survival
Hide Description PFS was defined as the time from first study drug administration to objective tumor progression or death from any cause.
Time Frame End of trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Median (95% Confidence Interval)
Unit of Measure: days
PP set
118
(65 to 174)
ITT set
113
(77 to 167)
6.Secondary Outcome
Title Incidence of Adverse Events, Serious Adverse Events, and Death.
Hide Description [Not Specified]
Time Frame End of trial
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title RAD001
Hide Arm/Group Description:
10 mg/day
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: % participants
Patients with any AE 100
AE with suspected relation to study drug 97.83
AE leading to dose adjustment or interruption 53.26
AE leading to permanent discontinuation 27.17
AE requiring concomitant medication 90.22
Patients with serious adverse event (SAE) 46.74
SAE suspected relation to study drug 23.91
SAE leading to permanent discontinuation 10.87
Patients died 10.87
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description two 5 mg tablets orally, once daily at the same time every day immediately after a meal
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   43/92 (46.74%) 
Blood and lymphatic system disorders   
Anaemia † 1  4/92 (4.35%) 
Cardiac disorders   
Atrial fibrillation † 1  1/92 (1.09%) 
Atrial flutter † 1  1/92 (1.09%) 
Cardiac arrest † 1  1/92 (1.09%) 
Cor pulmonale † 1  1/92 (1.09%) 
Tricuspid valve incompetence † 1  1/92 (1.09%) 
Gastrointestinal disorders   
Abdominal pain † 1  2/92 (2.17%) 
Ascites † 1  2/92 (2.17%) 
Colitis † 1  1/92 (1.09%) 
Diarrhoea † 1  1/92 (1.09%) 
Ileus † 1  1/92 (1.09%) 
Large intestine polyp † 1  1/92 (1.09%) 
Oesophagitis † 1  1/92 (1.09%) 
Subileus † 1  1/92 (1.09%) 
Vomiting † 1  1/92 (1.09%) 
General disorders   
Asthenia † 1  4/92 (4.35%) 
Chest pain † 1  1/92 (1.09%) 
Condition aggravated † 1  2/92 (2.17%) 
General physical health deterioration † 1  2/92 (2.17%) 
Mucosal inflammation † 1  1/92 (1.09%) 
Multi-organ failure † 1  1/92 (1.09%) 
Oedema peripheral † 1  1/92 (1.09%) 
Pyrexia † 1  4/92 (4.35%) 
Hepatobiliary disorders   
Cholestasis † 1  1/92 (1.09%) 
Infections and infestations   
Anal infection † 1  1/92 (1.09%) 
Bacteraemia † 1  1/92 (1.09%) 
Cellulitis † 1  1/92 (1.09%) 
Erysipelas † 1  1/92 (1.09%) 
Gastrointestinal infection † 1  1/92 (1.09%) 
Herpes zoster † 1  1/92 (1.09%) 
Pneumonia † 1  2/92 (2.17%) 
Pneumonia bacterial † 1  1/92 (1.09%) 
Postoperative abscess † 1  1/92 (1.09%) 
Respiratory tract infection † 1  1/92 (1.09%) 
Upper respiratory tract infection † 1  1/92 (1.09%) 
Injury, poisoning and procedural complications   
Lumbar vertebral fracture † 1  1/92 (1.09%) 
Investigations   
Blood creatinine increased † 1  1/92 (1.09%) 
Metabolism and nutrition disorders   
Dehydration † 1  2/92 (2.17%) 
Fluid overload † 1  1/92 (1.09%) 
Hyperglycaemia † 1  1/92 (1.09%) 
Hyponatraemia † 1  1/92 (1.09%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1  1/92 (1.09%) 
Bone pain † 1  1/92 (1.09%) 
Fistula † 1  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm progression † 1  4/92 (4.35%) 
Nervous system disorders   
Aphasia † 1  1/92 (1.09%) 
Hemiparesis † 1  1/92 (1.09%) 
Spinal cord compression † 1  1/92 (1.09%) 
Tremor † 1  1/92 (1.09%) 
Psychiatric disorders   
Depression † 1  1/92 (1.09%) 
Hallucination † 1  1/92 (1.09%) 
Renal and urinary disorders   
Renal failure † 1  3/92 (3.26%) 
Renal failure acute † 1  4/92 (4.35%) 
Reproductive system and breast disorders   
Vaginal haemorrhage † 1  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  1/92 (1.09%) 
Dyspnoea † 1  3/92 (3.26%) 
Dyspnoea exertional † 1  1/92 (1.09%) 
Epistaxis † 1  1/92 (1.09%) 
Interstitial lung disease † 1  1/92 (1.09%) 
Lung disorder † 1  1/92 (1.09%) 
Nasal septum deviation † 1  1/92 (1.09%) 
Oropharyngeal pain † 1  1/92 (1.09%) 
Pleural effusion † 1  4/92 (4.35%) 
Pneumonitis † 1  1/92 (1.09%) 
Pulmonary arterial hypertension † 1  1/92 (1.09%) 
Pulmonary embolism † 1  1/92 (1.09%) 
Respiratory failure † 1  1/92 (1.09%) 
Skin and subcutaneous tissue disorders   
Rash erythematous † 1  2/92 (2.17%) 
Vascular disorders   
Deep vein thrombosis † 1  2/92 (2.17%) 
Hypertension † 1  1/92 (1.09%) 
Varicose vein † 1  1/92 (1.09%) 
Venous thrombosis † 1  1/92 (1.09%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   90/92 (97.83%) 
Blood and lymphatic system disorders   
Anaemia † 1  25/92 (27.17%) 
Thrombocytopenia † 1  10/92 (10.87%) 
Cardiac disorders   
Tachycardia † 1  6/92 (6.52%) 
Gastrointestinal disorders   
Abdominal pain † 1  23/92 (25.00%) 
Aphthous stomatitis † 1  11/92 (11.96%) 
Ascites † 1  5/92 (5.43%) 
Constipation † 1  15/92 (16.30%) 
Diarrhoea † 1  36/92 (39.13%) 
Dry mouth † 1  8/92 (8.70%) 
Nausea † 1  27/92 (29.35%) 
Stomatitis † 1  23/92 (25.00%) 
Vomiting † 1  16/92 (17.39%) 
General disorders   
Asthenia † 1  39/92 (42.39%) 
Chest pain † 1  7/92 (7.61%) 
Fatigue † 1  30/92 (32.61%) 
Mucosal inflammation † 1  36/92 (39.13%) 
Oedema peripheral † 1  29/92 (31.52%) 
Pain † 1  7/92 (7.61%) 
Pyrexia † 1  25/92 (27.17%) 
Infections and infestations   
Bronchitis † 1  5/92 (5.43%) 
Rhinitis † 1  9/92 (9.78%) 
Urinary tract infection † 1  6/92 (6.52%) 
Investigations   
Alanine aminotransferase increased † 1  7/92 (7.61%) 
Aspartate aminotransferase increased † 1  6/92 (6.52%) 
Blood creatinine increased † 1  8/92 (8.70%) 
Platelet count decreased † 1  6/92 (6.52%) 
Weight decreased † 1  12/92 (13.04%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  36/92 (39.13%) 
Hypercholesterolaemia † 1  15/92 (16.30%) 
Hyperglycaemia † 1  12/92 (13.04%) 
Hypertriglyceridaemia † 1  10/92 (10.87%) 
Hypocalcaemia † 1  5/92 (5.43%) 
Hypophosphataemia † 1  8/92 (8.70%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  11/92 (11.96%) 
Back pain † 1  16/92 (17.39%) 
Musculoskeletal pain † 1  5/92 (5.43%) 
Myalgia † 1  5/92 (5.43%) 
Pain in extremity † 1  10/92 (10.87%) 
Nervous system disorders   
Dysgeusia † 1  23/92 (25.00%) 
Headache † 1  16/92 (17.39%) 
Psychiatric disorders   
Insomnia † 1  9/92 (9.78%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  36/92 (39.13%) 
Dyspnoea † 1  29/92 (31.52%) 
Epistaxis † 1  26/92 (28.26%) 
Pneumonitis † 1  7/92 (7.61%) 
Skin and subcutaneous tissue disorders   
Acne † 1  5/92 (5.43%) 
Dry skin † 1  12/92 (13.04%) 
Nail disorder † 1  13/92 (14.13%) 
Palmar-plantar erythrodysaesthesia syndrome † 1  5/92 (5.43%) 
Pruritus † 1  20/92 (21.74%) 
Rash † 1  53/92 (57.61%) 
Vascular disorders   
Hypertension † 1  6/92 (6.52%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00688753    
Other Study ID Numbers: CRAD001LFR08
2008-006181-28
First Submitted: May 30, 2008
First Posted: June 3, 2008
Results First Submitted: October 21, 2015
Results First Posted: November 26, 2015
Last Update Posted: September 2, 2016