AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

Amgen

Status and phase: Completed; Phase 2

Conditions: Advanced Renal Cell Carcinoma

Treatments: Drug: AMG 386 placebo IV; Drug: Sorafenib; Drug: AMG 386

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467025

20060159

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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152 participants in 3 patient groups

Arm A

Experimental group

Treatment:

Drug: AMG 386

Drug: AMG 386 placebo IV

Drug: Sorafenib

Arm B

Experimental group

Treatment:

Drug: AMG 386

Drug: Sorafenib

Arm C

Active Comparator group

Treatment:

Drug: AMG 386 placebo IV

Drug: Sorafenib