Renal Cell Carcinoma
Conditions
Keywords
RCC, Renal cell cancer, Avastin, Sutent
Brief summary
This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.
Interventions
DRUGbevacizumab
Intravenous repeating dose
DRUGsunitinib
Oral repeating dose
DRUGplacebo
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Histologically confirmed metastatic RCC * Measurable disease, as defined by RECIST * Age ≥ 18 years * ECOG performance status of 0 or 1 * Prior nephrectomy * Ability and capacity to comply with study and follow-up procedures
Exclusion criteria
* RCC with predominantly sarcomatoid features * Prior systemic or adjuvant therapy for RCC * Radiotherapy for RCC within 28 days prior to Day 1 * Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or other similar agents * Current need for dialysis * Life expectancy of \< 12 weeks * Current, recent, or planned participation in an experimental drug study * Inadequate organ function * Active infection or fever \> 38.5°C within 3 days of starting treatment * History of other malignancies within 5 years prior to Day 1 * Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results * Inadequately controlled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Class II or greater CHF * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Known CNS disease except for treated brain metastasis * Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 1 * History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Major surgical procedure or anticipation of need for major surgical procedure during the course of the study * Serious, non-healing wound; active ulcer; or untreated bone fracture * Known hypersensitivity to any component of bevacizumab * Pregnancy (positive pregnancy test) or lactation * Current, ongoing treatment with full-dose warfarin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | 5 months | Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 9 |
| Total | 16 |
Baseline characteristics
| Characteristic | Bevacizumab + Sunitinib | Placebo + Sunitinib | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 7 Participants | 11 Participants |
| Age Continuous | 60.4 years STANDARD_DEVIATION 11.8 | 58.7 years STANDARD_DEVIATION 7 | 59.4 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 12 Participants |
Outcome results
Primary
All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)
Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.
Time frame: 5 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Oral Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Haemolysis | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Thrombocytopenia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Bradycardia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Ear Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypothyroidism | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Diarrhoea | 3 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Nausea | 4 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Vomiting | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Gastroesphagael Reflux Disease | 2 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Constipation | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dyspepsia | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Abdominal Distension | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Stomach Discomfort | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Fatigue | 3 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Mucosal Inflammation | 2 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pyrexia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Infuenza Like Illness | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Chest Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Abdominal Abscess | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Otitis Media | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Fungal Infection | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Influenza | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Sinusitis | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Contusion | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Protein Urine | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Throat Tightness | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Blood Pressure Increased | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Decreased Appetite | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypoglycaemia | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Back Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Musculoskeletal Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Neck Pain | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pain in Extremity | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Headache | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dysgeusia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypogeusia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dizziness | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Tremor | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Anxiety | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Affect Lability | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Chromaturia | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Haematuria | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pharyngolaryngeal Pain | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Epistaxis | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pulmonary Embolism | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Rash | 4 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Palmar-Plantar Erythrodysaesthesia | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Yellow Skin | 2 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dry Skin | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Alopecia | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Night Sweats | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Nail Discolouration | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Petechiae | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Decubitus Ulcer | 0 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Urticaria | 1 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypertension | 2 participants |
| Bevacizumab + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypertensive Crisis | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Decreased Appetite | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypertensive Crisis | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Petechiae | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Haemolysis | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypoglycaemia | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Thrombocytopenia | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Throat Tightness | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Bradycardia | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Back Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Ear Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Alopecia | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypothyroidism | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Musculoskeletal Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Diarrhoea | 4 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Epistaxis | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Nausea | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Neck Pain | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Vomiting | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Urticaria | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Gastroesphagael Reflux Disease | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pain in Extremity | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Constipation | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pulmonary Embolism | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dyspepsia | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Headache | 3 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Abdominal Distension | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Night Sweats | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Stomach Discomfort | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dysgeusia | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Oral Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Fatigue | 4 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Rash | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Mucosal Inflammation | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypogeusia | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pyrexia | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Decubitus Ulcer | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Infuenza Like Illness | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dizziness | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Chest Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Pharyngolaryngeal Pain | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Palmar-Plantar Erythrodysaesthesia | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Abdominal Abscess | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Tremor | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Otitis Media | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Nail Discolouration | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Fungal Infection | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Anxiety | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Influenza | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Yellow Skin | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Sinusitis | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Affect Lability | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Contusion | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Hypertension | 3 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Protein Urine | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Chromaturia | 2 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Dry Skin | 0 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Blood Pressure Increased | 1 participants |
| Placebo + Sunitinib | All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher) | Haematuria | 0 participants |