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Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

Primary Purpose

Anemia, Solid Tumors

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Solid tumors, Multicycle chemotherapy, NESP

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • Subject with solid tumour(s)
  • Anaemia (hgb less than or equal to 11.0 g/dL
  • Planned to receive cyclic chemotherapy
  • At least 6-month life expectancy
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Adequate renal and liver function
  • At least 18 years of age

Exclusion Criteria:

  • Central nervous system disease
  • Iron deficiency
  • Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
  • Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
  • History of any seizure disorder
  • Cardiac disease
  • Active infection or inflammatory disease
  • Known positive test for HIV infection
  • Known primary haematologic disorder which could cause anaemia
  • Use of other investigational agent(s)/device(s)
  • Pregnant or breast feeding
  • Known hypersensitivity to any recombinant mammalian derived product

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    NESP - Schedule 1 Part A

    NESP - Schedule 2 Part A

    Placebo - Schedule 1 Part A

    NESP - Schedule 1 Part B

    Placebo - Schedule 2 Part A

    NESP - Schedule 2 Part B

    Arm Description

    Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks

    NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks

    Placebo Q3W for 12 weeks

    Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks.

    Placebo Q4W for 12 weeks

    Open-label NESP at the dose of study drug administered at the end of Part A

    Outcomes

    Primary Outcome Measures

    Occurence of adverse events and antibody formation to NESP

    Secondary Outcome Measures

    Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window
    Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions
    Relationship between these QOL measurements and hgb
    Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase
    Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
    Time to hgb response and hgb correction after the initiation of treatment
    Change in hgb measured at the end of the treatment phase compared to baseline

    Full Information

    First Posted
    October 4, 2007
    Last Updated
    May 6, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00540384
    Brief Title
    Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
    Official Title
    A Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1999 (undefined)
    Primary Completion Date
    March 2002 (Actual)
    Study Completion Date
    June 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy. Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A. Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Solid Tumors
    Keywords
    Anemia, Solid tumors, Multicycle chemotherapy, NESP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    405 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NESP - Schedule 1 Part A
    Arm Type
    Experimental
    Arm Description
    Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
    Arm Title
    NESP - Schedule 2 Part A
    Arm Type
    Experimental
    Arm Description
    NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
    Arm Title
    Placebo - Schedule 1 Part A
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Q3W for 12 weeks
    Arm Title
    NESP - Schedule 1 Part B
    Arm Type
    Experimental
    Arm Description
    Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks.
    Arm Title
    Placebo - Schedule 2 Part A
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Q4W for 12 weeks
    Arm Title
    NESP - Schedule 2 Part B
    Arm Type
    Experimental
    Arm Description
    Open-label NESP at the dose of study drug administered at the end of Part A
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
    Intervention Description
    Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
    Primary Outcome Measure Information:
    Title
    Occurence of adverse events and antibody formation to NESP
    Time Frame
    throughout the study
    Secondary Outcome Measure Information:
    Title
    Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window
    Time Frame
    during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
    Title
    Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions
    Time Frame
    throughout the study
    Title
    Relationship between these QOL measurements and hgb
    Title
    Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase
    Time Frame
    during treatment phase
    Title
    Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
    Time Frame
    during the treatment phase
    Title
    Time to hgb response and hgb correction after the initiation of treatment
    Time Frame
    after the initiation of treatment
    Title
    Change in hgb measured at the end of the treatment phase compared to baseline
    Time Frame
    baseline to end of the treatment phase

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject with solid tumour(s) Anaemia (hgb less than or equal to 11.0 g/dL Planned to receive cyclic chemotherapy At least 6-month life expectancy Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 Adequate renal and liver function At least 18 years of age Exclusion Criteria: Central nervous system disease Iron deficiency Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation History of any seizure disorder Cardiac disease Active infection or inflammatory disease Known positive test for HIV infection Known primary haematologic disorder which could cause anaemia Use of other investigational agent(s)/device(s) Pregnant or breast feeding Known hypersensitivity to any recombinant mammalian derived product
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12957457
    Citation
    Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.
    Results Reference
    result
    Links:
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_980291.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

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