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NCT Number: NCT00540384

Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) 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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Solid Tumors

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Drug

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Primary outcomes

  1. Occurence of adverse events and antibody formation to NESP

    Time frame: throughout the study

Secondary outcomes

  1. 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

    Time frame: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12

  2. 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

    Time frame: throughout the study

  3. Relationship between these QOL measurements and hgb

  4. 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

    Time frame: during treatment phase

  5. Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response

    Time frame: during the treatment phase

  6. Time to hgb response and hgb correction after the initiation of treatment

    Time frame: after the initiation of treatment

  7. Change in hgb measured at the end of the treatment phase compared to baseline

    Time frame: baseline to end of the treatment phase

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Oct 8, 2007
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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