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

Phase 1

Completed

• Conditions: Anemia; Solid Tumors
• Interventions: Drug: Placebo; Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

• Registration Number: NCT00540384
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2002-03
• Study Completion: 2002-06
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-04
• Study First Posted: 2007-10-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-06
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 405

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo - Schedule 1 Part A	Placebo	Placebo Q3W for 12 weeks
NESP - Schedule 1 Part A	Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)	Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
NESP - Schedule 2 Part A	Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)	NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
NESP - Schedule 1 Part B	Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)	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 - Schedule 2 Part A	Placebo	Placebo Q4W for 12 weeks
NESP - Schedule 2 Part B	Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)	Open-label NESP at the dose of study drug administered at the end of Part A

Primary Outcome Measures

Name	Time	Method
Occurence of adverse events and antibody formation to NESP	throughout the study

Secondary Outcome Measures

Name	Time	Method
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
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response	during the treatment phase
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
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
Time to hgb response and hgb correction after the initiation of treatment	after the initiation of treatment
Change in hgb measured at the end of the treatment phase compared to baseline	baseline to end of the treatment phase