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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467025
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 3/4 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467025


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00467025    
Other Study ID Numbers: 20060159
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: February 2016
Keywords provided by Amgen:
Metastatic clear cell carcinoma of the kidney
RCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
 Sorafenib
Trebananib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors