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

February 23, 2016 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Active Comparator: Arm C
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 2 3/4 years
2 3/4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: 2 3/4 years
2 3/4 years
Duration of response (DOR)
Time Frame: 2 3/4 years
2 3/4 years
Change in continuous measures of tumor burden
Time Frame: 2 3/4 years
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
Time Frame: 2 3/4 years
2 3/4 years
Incidence of AEs and significant laboratory changes
Time Frame: 2 3/4 years
2 3/4 years
Incidence of the occurrence of anti-AMG 386 antibody formation
Time Frame: 2 3/4 years
2 3/4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20060159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Renal Cell Carcinoma

Clinical Trials on AMG 386

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe