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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

Tracking Information
First Submitted Date  ICMJE April 26, 2007
First Posted Date  ICMJE April 27, 2007
Last Update Posted Date March 23, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)		 Progression Free Survival [ Time Frame: 2 3/4 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
  • Objective response rate (ORR) [ Time Frame: 2 3/4 years ]
  • Duration of response (DOR) [ Time Frame: 2 3/4 years ]
  • Change in continuous measures of tumor burden [ Time Frame: 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 ]
  • Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ]
  • Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Advanced Renal Cell Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm A
    Interventions:
    • Drug: AMG 386
    • Drug: Sorafenib
    • Drug: AMG 386 placebo IV
  • Experimental: Arm B
    Interventions:
    • Drug: AMG 386
    • Drug: Sorafenib
  • Active Comparator: Arm C
    Interventions:
    • Drug: Sorafenib
    • Drug: AMG 386 placebo IV
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2012)		 152
Original Enrollment  ICMJE
 (submitted: April 26, 2007)		 150
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Belgium,   France,   Poland,   United States
 
Administrative Information
NCT Number  ICMJE NCT00467025
Other Study ID Numbers  ICMJE 20060159
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amgen
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP