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Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment

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ClinicalTrials.gov Identifier: NCT01949545
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : October 21, 2016
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 24, 2013
Results First Submitted Date  ICMJE August 25, 2016
Results First Posted Date  ICMJE October 21, 2016
Last Update Posted Date May 2, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
    The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.
  • Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
    The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
Influence of Hepatic Impairment on Area Under the Curve [ Time Frame: Cycle 1 Day 16 ]
The primary endpoints are the area under the curve (both area under the curve, from time 0 to the last concentration measured [AUC0-last] and area under the curve, from time 0 extrapolated to infinity [AUC0-inf]) of carfilzomib at C1D16.
Change History Complete list of historical versions of study NCT01949545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
  • Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Clearance of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Terminal Half-life of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Mean Residence Time (MRT) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m² [ Time Frame: Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
    The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.
  • Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
    The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.
  • Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Terminal Half-life of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Clearance of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Mean Residence Time (MRT) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m² [ Time Frame: Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Terminal Half-life for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Mean Residence Time (MRT) for Metabolite PR-389/M14 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Terminal Half-life for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Mean Residence Time (MRT) for Metabolite PR-413/M15 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Terminal Half-life for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Mean Residence Time (MRT) for Metabolite PR-519/M16 [ Time Frame: Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion. ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks ]
    Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship. Adverse events were graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2013)
  • Influence of Hepatic Impairment on Additional Pharmacokinetics (PK) Parameters at Cycle 1 Day 16 (C1D16) [ Time Frame: Cycle 1 Day 16 ]
    Pharmacokinetics (PK) parameters comparison between subject cohorts at Cycle 1 Day 16 (C1D16), including maximum plasma concentration (Cmax), time to maximum concentration (tmax), clearance (CL), terminal half-life (t1/2), volume of distribution (Vd), and mean residence time (MRT)
  • Influence of Hepatic Impairment on Additional Pharmacokinetics (PK) Parameters at Cycle 2 Day 1 (C2D1) [ Time Frame: Cycle 2 Day 1 ]
    Pharmacokinetics (PK) parameters comparison between subject cohorts at Cycle 2 Day 1 (C2D1), including AUC0-last, AUC0-inf, Cmax, tmax, CL, t1/2, Vd, and MRT
  • Influence of Hepatic Impairment on Additional Pharmacokinetics (PK) parameters for major metabolites [ Time Frame: Cycle 1 Day 16 and Cycle 2 Day 1 ]
    Evaluation of pharmacokinetics (PK) parameters for major metabolites (metabolites PR-389/M14, PR-413/M15, and PR-519/M16) at Cycle 1 Day 16 (C1D16) and Cycle 2 Day 1 (C2D1) including AUC0-last, AUC0-inf, Cmax, tmax, t1/2, and MRT
  • Safety and Tolerability [ Time Frame: 24 months ]
    Safety and tolerability of carfilzomib: Incidence, severity, and causal relationship of all AEs including SAEs; incidence of laboratory shifts to or from normal range for key analytes; and CTCAE severity grade relative to baseline in key laboratory parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: September 19, 2013)
  • Exploratory Objectives: Best Overall Response Rate (ORR) [ Time Frame: 48 months ]
    Response categories and Best Overall Response Rate (ORR) will be evaluated consistent with tumor type as specified in the Statistical Analysis Plan (SAP). ORR will be summarized across hepatic impairment cohorts by the incidence (frequency and proportion).
  • Exploratory Objectives: Duration of Response (DOR) [ Time Frame: 48 months ]
    Duration of response (DOR) will be measured from the first indication of an objective response until relapse or death due to any cause; DOR will be summarized by Kaplan-Meier estimates by cohort for subjects who respond with partial response (PR) or better only.
 
Descriptive Information
Brief Title  ICMJE Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
Official Title  ICMJE An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Advanced Malignancies and Varying Degrees of Hepatic Impairment
Brief Summary The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Solid Tumors
  • Hematologic Malignancies
  • Hepatic Impairment
Intervention  ICMJE Drug: Carfilzomib
Carfilzomib was administered by IV injection over 30 minutes
Other Name: Kyprolis® (carfilzomib) for Injection
Study Arms  ICMJE
  • Experimental: Normal Hepatic Function
    Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
    Intervention: Drug: Carfilzomib
  • Experimental: Mild Hepatic Impairment
    Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
    Intervention: Drug: Carfilzomib
  • Experimental: Moderate Hepatic Impairment
    Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
    Intervention: Drug: Carfilzomib
  • Experimental: Severe Hepatic Impairment
    (Bilirubin > 3 × ULN; any AST) Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
    Intervention: Drug: Carfilzomib
Publications * Brown J, Plummer R, Bauer TM, Anthony S, Sarantopoulos J, De Vos F, White M, Schupp M, Ou Y, Vaishampayan U. Pharmacokinetics of carfilzomib in patients with advanced malignancies and varying degrees of hepatic impairment: an open-label, single-arm, phase 1 study. Exp Hematol Oncol. 2017 Oct 3;6:27. doi: 10.1186/s40164-017-0086-1. eCollection 2017.

*   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: August 25, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2013)
40
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies)
  2. At least ≥ 2 prior treatment regimens for the underlying malignancy
  3. Confirmed advanced solid tumor or hematologic malignancy
  4. Measurable or evaluable disease
  5. Clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. Hepatic impairment will be assessed as per National Cancer Institute Organ Dysfunction Working Group Criteria (NCI-ODWG) schema and will fall into one of the following three categories:

    • Cohort 2 (mild): Bilirubin > 1-1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) > ULN, but bilirubin ≤ ULN
    • Cohort 3 (moderate): ≥ 1.6-3 × ULN; any AST
    • Cohort 4 (severe): Bilirubin > 3 × ULN; any AST

    Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function:

    All subjects enrolled with normal hepatic function (N=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion

    #5, which should be substituted with the following criterion to be enrolled into the study:

    - Cohort 1 (normal hepatic function): Bilirubin ≤ ULN; AST ≤ ULN

  6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  7. Left ventricular ejection fraction (LVEF) ≥ 40%
  8. Adequate renal function (calculated creatinine clearance ≥ 30 mL/min)
  9. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment

Key Exclusion Criteria:

  1. Subjects with symptomatic brain metastasis or central nervous system (CNS) disease
  2. Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrolment
  3. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests [bilirubin, AST] will be allowed)
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 France,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01949545
Other Study ID Numbers  ICMJE CFZ002
20130402 ( Other Identifier: Amgen )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2017

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