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

Amgen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Anemia

Solid Tumors

Treatments

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

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00540384

980291

Details and patient eligibility

About

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.

Enrollment

405 estimated patients

Sex

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

405 participants in 6 patient groups, including a placebo group

NESP - Schedule 1 Part A

Experimental group

Description:

Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks

Treatment:

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

NESP - Schedule 2 Part A

Experimental group

Description:

NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks

Treatment:

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

Placebo - Schedule 1 Part A

Placebo Comparator group

Description:

Placebo Q3W for 12 weeks

Treatment:

Drug: Placebo

NESP - Schedule 1 Part B

Experimental group

Description:

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.

Treatment:

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

Placebo - Schedule 2 Part A

Placebo Comparator group

Description:

Placebo Q4W for 12 weeks

Treatment:

Drug: Placebo

NESP - Schedule 2 Part B

Experimental group

Description:

Open-label NESP at the dose of study drug administered at the end of Part A