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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00540384
First received: October 4, 2007
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Anemia
Solid Tumors
Drug: Placebo
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Occurence of adverse events and antibody formation to NESP [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

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 [ Time Frame: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Relationship between these QOL measurements and hgb [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response [ Time Frame: during the treatment phase ] [ Designated as safety issue: No ]
  • Time to hgb response and hgb correction after the initiation of treatment [ Time Frame: after the initiation of treatment ] [ Designated as safety issue: No ]
  • Change in hgb measured at the end of the treatment phase compared to baseline [ Time Frame: baseline to end of the treatment phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 405
Study Start Date: July 1999
Study Completion Date: June 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NESP - Schedule 1 Part A
Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Experimental: NESP - Schedule 2 Part A
NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Placebo Comparator: Placebo - Schedule 1 Part A
Placebo Q3W for 12 weeks
Drug: Placebo
Placebo
Experimental: NESP - Schedule 1 Part B
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.
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Placebo Comparator: Placebo - Schedule 2 Part A
Placebo Q4W for 12 weeks
Drug: Placebo
Placebo
Experimental: NESP - Schedule 2 Part B
Open-label NESP at the dose of study drug administered at the end of Part A
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

  Eligibility

Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540384

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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00540384     History of Changes
Other Study ID Numbers: 980291
Study First Received: October 4, 2007
Last Updated: May 6, 2013
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
Canada: Health Canada
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Sweden: Medical Products Agency
Australia: Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by Amgen:
Anemia
Solid tumors
Multicycle chemotherapy
NESP

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014