AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00467025

Purpose

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	Intervention	Phase
Advanced Renal Cell Carcinoma	Drug: AMG 386 Drug: Sorafenib	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate AMG 386

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate (ORR) [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
Duration of response (DOR) [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
Change in continuous measures of tumor burden [ Time Frame: 2 3/4 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ] [ Designated as safety issue: Yes ]
Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467025

Show 44 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060159
Study First Received:	April 26, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00467025
Health Authority:	Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Austria: Bundesamt für Sicherheit im Gesundheitswesen; Belgium: Directorate-General for Medicinal Products; France: Afssaps - French Health Products Safety Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Agencia Española de Medicamentos y Productos Sanitarios; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Amgen:

Metastatic clear cell carcinoma of the kidney
RCC

Study placed in the following topic categories:

Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Adenocarcinoma, Clear Cell
Urologic Diseases
Kidney Neoplasms

Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Clear cell renal cell carcinoma
Sorafenib
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009