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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00467025
First received: April 26, 2007
Last updated: February 21, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 152
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00467025     History of Changes
Other Study ID Numbers: 20060159
Study First Received: April 26, 2007
Last Updated: February 21, 2014
Health Authority: Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information
Austria: Bundesamt für Sicherheit im Gesundheitswesen
Belgium: Directorate-General for Medicinal Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014