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

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:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

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

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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.

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013