Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPI-2012 · 4 trials · 3 indications
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
PK samples will be collected at predetermined time intervals. AUC is calculated in the plot of plasma concentration versus time curve
| Arm | Type | Description |
|---|---|---|
| (Arm 1): SPI-2012 and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| (Arm 2): Pegfilgrastim and TC | EXPERIMENTAL | At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment. |
| Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \[G-CSF\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. |
| Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC) | EXPERIMENTAL | Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes. |
| SPI-2012 | EXPERIMENTAL | * SPI-2012 (13.2 mg/0.6 mL fixed dose, equivalent to 3.6 mg G-CSF per cycle) * Supplied in 1 mL prefilled, single-use syringes for subcutaneous injection * Administered on Day 2 of each cycle after TC administration |
| Name | Type | Description |
|---|---|---|
| SPI-2012 | DRUG | Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle |
| Pegfilgrastim | DRUG | Subcutaneous injection administered on Day 2 of each cycle. |
| Docetaxel | DRUG | 75mg/m\^2 IV infusion administered on Day 1 of each cycle |
| Cyclophosphamide | DRUG | 600mg/m\^2 IV infusion administered on Day 1 of each cycle |
Key Inclusion Criteria: * New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer * Candidate for adjuvant or neo-adjuvant TC chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Absolute neut...
SPI-2012 is an investigational small molecule being developed for the management of neutropenia in patients with breast cancer. It has been studied in clinical trials comparing it to pegfilgrastim for reducing neutropenia in breast cancer patients receiving docetaxel and cyclophosphamide chemotherapy.
SPI-2012 is being developed by Assertio Holdings, Inc. (NASDAQ: ASRT). The company has sponsored clinical trials of the drug for neutropenia in breast cancer patients.
SPI-2012 is in Phase 1 clinical development. While earlier Phase 2 and Phase 3 trials have been completed, the drug is still investigational and has not been approved by the FDA. It remains in active clinical development.
SPI-2012 has been studied in three completed trials: NCT01724866 (Phase 2, 148 patients), NCT02643420 (Phase 3, 406 patients), and NCT02953340 (Phase 3, 237 patients), all comparing it to pegfilgrastim for neutropenia in breast cancer. A Phase 1 pharmacokinetic trial (NCT03135951) enrolled 26 patients.
Yes, SPI-2012 is also known as eflapegrastim. A Phase 1 trial (NCT03135951) titled 'Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients' confirms that SPI-2012 and eflapegrastim refer to the same drug.