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

Phase 2

Completed

• Conditions: Advanced Renal Cell Carcinoma
• Interventions: Drug: AMG 386; Drug: Sorafenib; Drug: AMG 386 placebo IV

• Registration Number: NCT00467025
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-26
• Study First Submitted QC: 2007-04-26
• Study First Posted: 2007-04-27
• Study Start: 2007-05
• Primary Completion: 2010-04
• Study Completion: 2014-06
• Disposition First Submitted: 2015-04-06
• Disposition First Submitted QC: 2015-04-06
• Disposition First Posted: 2015-04-27
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A	Sorafenib	-
Arm A	AMG 386 placebo IV	-
Arm B	Sorafenib	-
Arm C	AMG 386 placebo IV	-
Arm A	AMG 386	-
Arm B	AMG 386	-
Arm C	Sorafenib	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	2 3/4 years

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 3/4 years
Duration of response (DOR)	2 3/4 years
Change in continuous measures of tumor burden	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
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