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Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00392821
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborators:
Novartis
Bayer
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Drug: Sorafenib
Drug: RAD001
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RAD001 and Sorafenib
Hide Arm/Group Description

RAD001 and Sorafenib

Sorafenib: Sorafenib

RAD001: RAD001

Period Title: Overall Study
Started 78
Completed 59
Not Completed 19
Arm/Group Title RAD001 and Sorafenib
Hide Arm/Group Description

RAD001 and Sorafenib

Sorafenib: Sorafenib

RAD001: RAD001

Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 78 participants
62.5
(44 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
24
  30.8%
Male
54
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 78 participants
78
1.Primary Outcome
Title Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001 and Sorafenib
Hide Arm/Group Description:

RAD001 and Sorafenib

Sorafenib: Sorafenib

RAD001: RAD001

Overall Number of Participants Analyzed 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of evaluable patients
13
(7 to 23)
2.Secondary Outcome
Title Progression-Free Survival.
Hide Description Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD001 and Sorafenib
Hide Arm/Group Description:

RAD001 and Sorafenib

Sorafenib: Sorafenib

RAD001: RAD001

Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: Months
5.45
(3.9 to 7.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD001 and Sorafenib
Hide Arm/Group Description

RAD001 and Sorafenib

Sorafenib: Sorafenib

RAD001: RAD001

All-Cause Mortality
RAD001 and Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RAD001 and Sorafenib
Affected / at Risk (%) # Events
Total   21/78 (26.92%)    
Cardiac disorders   
Ventricular tachycardia  1  1/78 (1.28%)  1
Gastrointestinal disorders   
Ascites  1  1/78 (1.28%)  1
Diarrhea  1  1/78 (1.28%)  1
Hemorrhage, GI  1  1/78 (1.28%)  1
Pain - stomach  1  1/78 (1.28%)  1
Vomiting  1  1/78 (1.28%)  1
General disorders   
Edema  1  1/78 (1.28%)  1
Fever  1  1/78 (1.28%)  1
Pain - chest  1  2/78 (2.56%)  2
Infections and infestations   
Infection - lung (pneumonia)  1  1/78 (1.28%)  1
Sepsis  1  1/78 (1.28%)  1
Injury, poisoning and procedural complications   
Hernia  1  1/78 (1.28%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/78 (2.56%)  2
Musculoskeletal and connective tissue disorders   
Pain - back  1  1/78 (1.28%)  1
Stabilization of thoracic spine  1  1/78 (1.28%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasm  1  2/78 (2.56%)  2
Nervous system disorders   
CNS Ischemia  1  4/78 (5.13%)  4
Renal and urinary disorders   
Kidney stones  1  1/78 (1.28%)  1
Nephrotic syndrome  1  1/78 (1.28%)  1
Proteinuria  1  1/78 (1.28%)  1
Renal failure  1  2/78 (2.56%)  2
Respiratory, thoracic and mediastinal disorders   
Chronic Obstructive Pulmonary Disease  1  1/78 (1.28%)  1
Dyspnea  1  1/78 (1.28%)  1
Pneumothorax  1  1/78 (1.28%)  1
Vascular disorders   
Vascular - atherosclerosis  1  1/78 (1.28%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAD001 and Sorafenib
Affected / at Risk (%) # Events
Total   78/78 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  48/78 (61.54%) 
Gastrointestinal disorders   
Nausea  1  46/78 (58.97%) 
Diarrhea  1  44/78 (56.41%) 
Vomiting  1  19/78 (24.36%) 
Abdominal Pain  1  18/78 (23.08%) 
Constipation  1  17/78 (21.79%) 
Gastroesophageal Reflux Disease  1  9/78 (11.54%) 
Mucositis Oral  1  8/78 (10.26%) 
Dysphagia  1  8/78 (10.26%) 
Gastrointestinal Pain  1  7/78 (8.97%) 
Oral Pain  1  6/78 (7.69%) 
Flatulence  1  5/78 (6.41%) 
Dry Mouth  1  4/78 (5.13%) 
General disorders   
Fatigue  1  55/78 (70.51%) 
Edema  1  32/78 (41.03%) 
Mucositis  1  17/78 (21.79%) 
Fever  1  14/78 (17.95%) 
Chest Pain  1  13/78 (16.67%) 
Pain  1  10/78 (12.82%) 
Chills  1  9/78 (11.54%) 
Infections and infestations   
Sinusitis  1  9/78 (11.54%) 
Urinary Tract Infection  1  7/78 (8.97%) 
Upper Respiratory Infection  1  4/78 (5.13%) 
Investigations   
Platelet Count Decreased  1  24/78 (30.77%) 
Creatinine Increased  1  17/78 (21.79%) 
Alkaline Phosphatase Increased  1  16/78 (20.51%) 
White Blood Cell Decreased  1  14/78 (17.95%) 
Weight Loss  1  13/78 (16.67%) 
Cholesterol High  1  11/78 (14.10%) 
Aspartate Aminotransferase Increased  1  10/78 (12.82%) 
Neutrophil Count Decreased  1  8/78 (10.26%) 
BUN Levels Increased  1  7/78 (8.97%) 
Alanine Aminotransferase Increased  1  7/78 (8.97%) 
LDH Level Increased  1  4/78 (5.13%) 
Metabolism and nutrition disorders   
Anorexia  1  33/78 (42.31%) 
Hyperglycemia  1  19/78 (24.36%) 
Hypophosphatemia  1  17/78 (21.79%) 
Hyperkalemia  1  11/78 (14.10%) 
Hypoalbuminemia  1  10/78 (12.82%) 
Hyperlipidemia  1  9/78 (11.54%) 
Hypertriglyceridemia  1  9/78 (11.54%) 
Dehydration  1  8/78 (10.26%) 
Hyponatremia  1  8/78 (10.26%) 
Hypocalcemia  1  6/78 (7.69%) 
Hypokalemia  1  5/78 (6.41%) 
Hyperuricemia  1  5/78 (6.41%) 
Hypercalcemia  1  4/78 (5.13%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  29/78 (37.18%) 
Pain in Extremity  1  14/78 (17.95%) 
Back Pain  1  13/78 (16.67%) 
Myalgia  1  12/78 (15.38%) 
Generalized Muscle Weakness  1  11/78 (14.10%) 
Neck Pain  1  5/78 (6.41%) 
Flank Pain  1  5/78 (6.41%) 
Nervous system disorders   
Headache  1  21/78 (26.92%) 
Dysgeusia  1  16/78 (20.51%) 
Peripheral Neuropathy  1  14/78 (17.95%) 
Dizziness  1  10/78 (12.82%) 
Ischemia Cerebrovascular  1  4/78 (5.13%) 
Psychiatric disorders   
Insomnia  1  13/78 (16.67%) 
Depression  1  8/78 (10.26%) 
Anxiety  1  8/78 (10.26%) 
Renal and urinary disorders   
Proteinuria  1  33/78 (42.31%) 
Hematuria  1  5/78 (6.41%) 
Acute Renal Failure  1  4/78 (5.13%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  24/78 (30.77%) 
Cough  1  24/78 (30.77%) 
Allergic Rhinitis  1  10/78 (12.82%) 
Epistaxis  1  8/78 (10.26%) 
Voice Alteration  1  7/78 (8.97%) 
Skin and subcutaneous tissue disorders   
Rash  1  64/78 (82.05%) 
Palmar-Plantar Erythrodysesthesia Syndrome  1  26/78 (33.33%) 
Pruritus  1  21/78 (26.92%) 
Alopecia  1  10/78 (12.82%) 
Dry Skin  1  6/78 (7.69%) 
Hyperhidrosis  1  6/78 (7.69%) 
Vascular disorders   
Hypertension  1  32/78 (41.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 877-691-7274
EMail: ASKSARAH@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00392821     History of Changes
Other Study ID Numbers: SCRI GU 44
CRAD001C2480
First Submitted: October 25, 2006
First Posted: October 26, 2006
Results First Submitted: February 10, 2014
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014