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

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.

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