Advanced Renal Cell Carcinoma
Conditions
Keywords
Metastatic clear cell carcinoma of the kidney, RCC
Brief summary
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
Interventions
DRUGAMG 386
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
DRUGSorafenib
400 mg PO BID
DRUGAMG 386 placebo IV
AMG 386 placebo IV
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a histologically confirmed metastatic RCC with a clear cell component * Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification. * Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications * Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening. * ECOG of 0 or 1
Exclusion criteria
Disease Related * Known history of central nervous system metastases. * Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma * Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization. Medications * Currently or previously treated with inhibitors of VEGF. * Currently or previously treated with inhibitors of angiopoietin or Tie2. * Currently or previously treated with bevacizumab. General Medical * Diagnosis of acute pancreatitis. * Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization * Major surgery within 30 days before randomization or still recovering from prior surgery * Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. Anti-hypertensive medications are permitted. Other * Other investigational procedures are excluded * Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 2 3/4 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) | 2 3/4 years |
| Change in continuous measures of tumor burden | 2 3/4 years |
| Objective response rate (ORR) | 2 3/4 years |
| Incidence of AEs and significant laboratory changes | 2 3/4 years |
| Incidence of the occurrence of anti-AMG 386 antibody formation | 2 3/4 years |
| Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data | 2 3/4 years |
Outcome results
None listed