Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects with Solid Tumours Receiving Multicycle Chemotherapy
Study Details
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.
Protocol Summary
Occurence of adverse events and antibody formation to NESP
Timeframe: throughout the study
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
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
Relationship between these QOL measurements and hgb
Timeframe: N/A
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
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
Timeframe: during the treatment phase
Time to hgb response and hgb correction after the initiation of treatment
Timeframe: after the initiation of treatment
Change in hgb measured at the end of the treatment phase compared to baseline
Timeframe: baseline to end of the treatment phase