AMG 386, 20060159 Phase 2, RCC 1st Line in Combination Wi... | NCT00467025

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

NCT00467025

Sponsor

Amgen

Status

Completed

Last Update Posted

Mar 23, 2016Estimated

Enrollment

152Actual

Phase

Phase 2

Conditions

Advanced Renal Cell Carcinoma

Interventions

AMG 386
Sorafenib
AMG 386 placebo IV

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Apr 2010Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 26, 2007

First Submission Date that Met QC Criteria

Apr 26, 2007

First Posted Date

Apr 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 6, 2015

Certification/Extension First Submitted that Passed QC Review

Apr 6, 2015

Certification/Extension First Posted Date

Apr 27, 2015Estimated

Last Update Submitted Date

Feb 23, 2016

Last Update Posted Date

Mar 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152Actual

Label	Type	Intervention Names
Arm A	Experimental	Drug: AMG 386 Drug: Sorafenib Drug: AMG 386 placebo IV
Arm B	Experimental	Drug: AMG 386 Drug: Sorafenib
Arm C	Active Comparator	Drug: Sorafenib Drug: AMG 386 placebo IV

Name	Type	Description	Arm Group Labels	Other Names
AMG 386	Drug	3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression	Arm A Arm B

Measure	Description	Time Frame
Progression Free Survival		2 3/4 years

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

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22692704	Derived	Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
C551398	trebananib
D000077157	Sorafenib

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals