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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540384
• Other study ID #: 980291
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2007
• Last updated: May 6, 2013
• Start date: July 1999
• Est. completion date: June 2002

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im GesundheitswesenCanada: Health CanadaGermany: Paul_Ehrlich-Institut Bundesamt fur Sera und ImpfstoffeSweden: Medical Products AgencyAustralia: Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: June 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Solid Tumors

Intervention

Drug:
• Placebo
Placebo
• Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & 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-bl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of adverse events and antibody formation to NESP		throughout the study	Yes
Secondary	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	No
Secondary	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	No
Secondary	Relationship between these QOL measurements and hgb			No
Secondary	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	No
Secondary	Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response		during the treatment phase	No
Secondary	Time to hgb response and hgb correction after the initiation of treatment		after the initiation of treatment	No
Secondary	Change in hgb measured at the end of the treatment phase compared to baseline		baseline to end of the treatment phase	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling