Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

Amgen405 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

405

Conditions

Anemia Solid Tumors

Interventions

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Occurence of adverse events and antibody formation to NESP

Time frame: throughout the study

Secondary Outcomes

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

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

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

Time frame: during treatment phase

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

Time frame: during the treatment phase

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

Time frame: after the initiation of treatment

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

Time frame: baseline to end of the treatment phase