Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Novel Erythropoiesis Stimulating Protein · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| NESP - Schedule 1 Part A | EXPERIMENTAL | Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks |
| NESP - Schedule 2 Part A | EXPERIMENTAL | NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks |
| Placebo - Schedule 1 Part A | PLACEBO_COMPARATOR | Placebo Q3W for 12 weeks |
| NESP - Schedule 1 Part B | EXPERIMENTAL | Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb \< 13.0g/dL and/or RBC transfusion in previous 2 weeks. |
| Placebo - Schedule 2 Part A | PLACEBO_COMPARATOR | Placebo Q4W for 12 weeks |
| NESP - Schedule 2 Part B | EXPERIMENTAL | Open-label NESP at the dose of study drug administered at the end of Part A |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) | DRUG | Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) |
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 ...