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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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Anemia, Solid Tumors

Thank you

Trial Information

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


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

Type of Study:

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

Outcome Measure:

Occurence of adverse events and antibody formation to NESP

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: Bundesamt für Sicherheit im Gesundheitswesen

Study ID:

980291

NCT ID:

NCT00540384

Start Date:

July 1999

Completion Date:

June 2002

Related Keywords:

  • Anemia
  • Solid Tumors
  • Anemia
  • Solid tumors
  • Multicycle chemotherapy
  • NESP
  • Anemia
  • Neoplasms

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