Clinical trial NCT00540384: Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anemia
Solid Tumors
Keywords: Anemia
Solid tumors
Multicycle chemotherapy
NESP
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 405
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurence of adverse events and antibody formation to NESP
timeFrame: throughout the study
Secondary outcomes:
measure: 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
timeFrame: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
measure: 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
timeFrame: throughout the study
measure: Relationship between these QOL measurements and hgb
measure: 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
timeFrame: during treatment phase
measure: Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
timeFrame: during the treatment phase
measure: Time to hgb response and hgb correction after the initiation of treatment
timeFrame: after the initiation of treatment
measure: Change in hgb measured at the end of the treatment phase compared to baseline
timeFrame: baseline to end of the treatment phase
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.