Trial Outcomes & Findings for Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus) (NCT NCT00651482)
NCT ID: NCT00651482
Last Updated: 2017-04-11
Results Overview
Progression-free survival (PFS) per RECIST criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
24 months
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Bevacizumab + RAD001 (Everolimus)
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Everolimus
Bevacizumab
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)
Baseline characteristics by cohort
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
Everolimus
Bevacizumab
|
|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 monthsProgression-free survival (PFS) per RECIST criteria
Outcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Progression-free Survival (PFS)
|
5.1 months
Interval 3.1 to 11.7
|
SECONDARY outcome
Timeframe: 24 monthsNumber of subjects with objective response (OR)
Outcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Objective Response (OR)
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Objective Response (OR) Duration
|
21.7 weeks
Interval 13.0 to 50.0
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Time-to-Treatment Failure (TTF)
|
5.1 months
Interval 1.9 to 11.7
|
SECONDARY outcome
Timeframe: 44 monthsOutcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Overall Survival (OS)
|
21.0 months
Interval 4.8 to 43.8
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Number of Subjects With Drug-related SAEs
|
3 participants
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Total Number of Drug-related SAEs
|
4 events
|
SECONDARY outcome
Timeframe: 24 monthsNumber of subjects whose treatment was discontinued due to toxicity
Outcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Treatment Discontinuation Due to Toxicity
|
4 participants
|
SECONDARY outcome
Timeframe: 24 monthsNumber of subjects whose treatment was discontinued due to disease progression
Outcome measures
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 Participants
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Treatment Discontinuation Due to Disease Progression
|
6 participants
|
Adverse Events
Bevacizumab + RAD001 (Everolimus)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 participants at risk
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Thrombotic microangiopath
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Inferior vena cava obstruction
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pain - Resection of left distal femur; ORIF of supracondylar fracture
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pain - Right hip pain progressively worsened
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture - Avulsion fractue of the lesser trochanter of R femur
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Vascular disorders - GI hemorrhage
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2
|
Other adverse events
| Measure |
Bevacizumab + RAD001 (Everolimus)
n=10 participants at risk
Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles
Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted)
Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
10/10 • Number of events 37
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
60.0%
6/10 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemolysis
|
10.0%
1/10 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Cardiac disorders - Other
|
30.0%
3/10 • Number of events 5
|
|
Cardiac disorders
Pericardial effusion
|
20.0%
2/10 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • Number of events 1
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Endocrine disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • Number of events 2
|
|
Eye disorders
Blurred vision
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Anal hemorrhage
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
60.0%
6/10 • Number of events 27
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 6
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 3
|
|
General disorders
Chills
|
30.0%
3/10 • Number of events 4
|
|
General disorders
Edema limbs
|
50.0%
5/10 • Number of events 6
|
|
General disorders
Fatigue
|
90.0%
9/10 • Number of events 13
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1
|
|
General disorders
General disorders and administration site conditions - Other
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
20.0%
2/10 • Number of events 3
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
10.0%
1/10 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
30.0%
3/10 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
30.0%
3/10 • Number of events 3
|
|
Investigations
Activated partial thromboplastin time prolonged
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
30.0%
3/10 • Number of events 6
|
|
Investigations
Alkaline phosphatase increased
|
60.0%
6/10 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
6/10 • Number of events 14
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • Number of events 2
|
|
Investigations
Cholesterol high
|
50.0%
5/10 • Number of events 15
|
|
Investigations
CPK increased
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Creatinine increased
|
90.0%
9/10 • Number of events 17
|
|
Investigations
INR increased
|
10.0%
1/10 • Number of events 2
|
|
Investigations
Investigations - Other
|
40.0%
4/10 • Number of events 6
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
20.0%
2/10 • Number of events 2
|
|
Investigations
Platelet count decreased
|
40.0%
4/10 • Number of events 8
|
|
Investigations
Weight gain
|
10.0%
1/10 • Number of events 3
|
|
Investigations
Weight loss
|
50.0%
5/10 • Number of events 7
|
|
Investigations
White blood cell decreased
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Acidosis
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
10/10 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
80.0%
8/10 • Number of events 18
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
8/10 • Number of events 27
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
3/10 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
70.0%
7/10 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
5/10 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
10.0%
1/10 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 2
|
|
Nervous system disorders
Cognitive disturbance
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Headache
|
30.0%
3/10 • Number of events 5
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • Number of events 2
|
|
Nervous system disorders
Sinus pain
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
2/10 • Number of events 2
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Number of events 4
|
|
Renal and urinary disorders
Chronic kidney disease
|
30.0%
3/10 • Number of events 4
|
|
Renal and urinary disorders
Hematuria
|
80.0%
8/10 • Number of events 15
|
|
Renal and urinary disorders
Proteinuria
|
100.0%
10/10 • Number of events 37
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
2/10 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
60.0%
6/10 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
40.0%
4/10 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.0%
6/10 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
4/10 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
40.0%
4/10 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
40.0%
4/10 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1
|
Additional Information
Associate Professor of Medicine (Oncology)
Stanford University Medical Center
Phone: 650-725-2078
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place