Anemia, Solid Tumors
Conditions
Keywords
Anemia, Solid tumors, Multicycle chemotherapy, NESP
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.
Interventions
DRUGPlacebo
Placebo
DRUGNovel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of adverse events and antibody formation to NESP | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 | throughout the study |
| Relationship between these QOL measurements and hgb | — |
| 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 | during treatment phase |
| 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 | during weeks 1-12, 1-4, 5-8, 9-12, and 5-12 |
| Time to hgb response and hgb correction after the initiation of treatment | after the initiation of treatment |
| Change in hgb measured at the end of the treatment phase compared to baseline | baseline to end of the treatment phase |
| Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response | during the treatment phase |
Outcome results
None listed