Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
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
1 other identifier
interventional
405
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 1999
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedMay 8, 2013
May 1, 2013
2.7 years
October 4, 2007
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of adverse events and antibody formation to NESP
throughout the study
Secondary Outcomes (7)
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
during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
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
throughout the study
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
during treatment phase
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
during the treatment phase
- +2 more secondary outcomes
Study Arms (6)
NESP - Schedule 1 Part A
EXPERIMENTALPart A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
NESP - Schedule 2 Part A
EXPERIMENTALNESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
Placebo - Schedule 1 Part A
PLACEBO COMPARATORPlacebo Q3W for 12 weeks
NESP - Schedule 1 Part B
EXPERIMENTALOpen-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 - Schedule 2 Part A
PLACEBO COMPARATORPlacebo Q4W for 12 weeks
NESP - Schedule 2 Part B
EXPERIMENTALOpen-label NESP at the dose of study drug administered at the end of Part A
Interventions
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Related Publications (1)
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.
PMID: 12957457RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
July 1, 1999
Primary Completion
March 1, 2002
Study Completion
June 1, 2002
Last Updated
May 8, 2013
Record last verified: 2013-05