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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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | HEC53856, rHuEPO |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
Novel Erythropoiesis Stimulating Protein is being studied for the treatment of anemia in patients with solid tumors who are receiving multicycle chemotherapy. It is an investigational therapy in the oncology therapeutic area, developed by Amgen Inc. under the ticker AMGN.
Novel Erythropoiesis Stimulating Protein is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor behind the clinical program evaluating the agent in anemic patients with solid tumors undergoing chemotherapy.
Novel Erythropoiesis Stimulating Protein is in Phase 1 clinical development. It has not been approved by the FDA and remains investigational. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
Novel Erythropoiesis Stimulating Protein has been evaluated in one completed Phase 1 trial, NCT00540384, titled a dose-finding study for the treatment of anemia in subjects with solid tumors receiving multicycle chemotherapy. The trial enrolled 405 participants, was randomized, double-blind, and placebo-controlled, and has completed.
Yes. Novel Erythropoiesis Stimulating Protein is also known as NESP and darbepoetin alfa. Readers searching for darbepoetin alfa or NESP are looking at the same Amgen asset, which is being studied in anemia associated with solid tumors and multicycle chemotherapy.