Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R) (NCT NCT00491738)
NCT ID: NCT00491738
Last Updated: 2009-04-10
Results Overview
Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
5 months
Results posted on
2009-04-10
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Sunitinib
Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
Placebo + Sunitinib
Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)
Baseline characteristics by cohort
| Measure |
Bevacizumab + Sunitinib
n=7 Participants
Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
Placebo + Sunitinib
n=9 Participants
Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
60.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 monthsGrades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.
Outcome measures
| Measure |
Bevacizumab + Sunitinib
n=7 Participants
Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
Placebo + Sunitinib
n=9 Participants
Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
|
|---|---|---|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Decubitus Ulcer
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Haemolysis
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Thrombocytopenia
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Bradycardia
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Ear Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Hypothyroidism
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Diarrhoea
|
3 participants
|
4 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Nausea
|
4 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Vomiting
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Gastroesphagael Reflux Disease
|
2 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Constipation
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Dyspepsia
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Abdominal Distension
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Stomach Discomfort
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Oral Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Fatigue
|
3 participants
|
4 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Mucosal Inflammation
|
2 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Pyrexia
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Infuenza Like Illness
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Chest Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Abdominal Abscess
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Otitis Media
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Fungal Infection
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Influenza
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Sinusitis
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Contusion
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Protein Urine
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Blood Pressure Increased
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Decreased Appetite
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Hypoglycaemia
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Back Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Musculoskeletal Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Neck Pain
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Pain in Extremity
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Headache
|
1 participants
|
3 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Dysgeusia
|
1 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Hypogeusia
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Dizziness
|
0 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Tremor
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Anxiety
|
1 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Affect Lability
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Chromaturia
|
0 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Haematuria
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Pharyngolaryngeal Pain
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Throat Tightness
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Epistaxis
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Pulmonary Embolism
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Rash
|
4 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Palmar-Plantar Erythrodysaesthesia
|
1 participants
|
2 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Yellow Skin
|
2 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Dry Skin
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Alopecia
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Night Sweats
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Nail Discolouration
|
0 participants
|
1 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Petechiae
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Urticaria
|
1 participants
|
0 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Hypertension
|
2 participants
|
3 participants
|
|
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Hypertensive Crisis
|
1 participants
|
0 participants
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Medical Communications Specialist
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER