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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00467025

Collaborator

(none)

152

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Renal Cell Carcinoma	Drug: AMG 386 Drug: Sorafenib Drug: AMG 386 placebo IV	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A	Drug: AMG 386 3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression Drug: Sorafenib 400 mg PO BID Drug: AMG 386 placebo IV AMG 386 placebo IV
Experimental: Arm B	Drug: AMG 386 3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression Drug: Sorafenib 400 mg PO BID
Active Comparator: Arm C	Drug: Sorafenib 400 mg PO BID Drug: AMG 386 placebo IV AMG 386 placebo IV

Arm

Intervention/Treatment

Experimental: Arm A

Drug: AMG 386

3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression

Drug: Sorafenib

400 mg PO BID

Drug: AMG 386 placebo IV

AMG 386 placebo IV

Experimental: Arm B

Drug: AMG 386

3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression

Drug: Sorafenib

400 mg PO BID

Active Comparator: Arm C

Drug: Sorafenib

400 mg PO BID

Drug: AMG 386 placebo IV

AMG 386 placebo IV

Outcome Measures

Primary Outcome Measures

Progression Free Survival [2 3/4 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)