SPI-2012

DRUG4 trials

Sponsors

Spectrum Pharmaceuticals, Inc

Conditions

Breast CancerNeutropeniaPharmacokinetics

Phase 1

Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

CompletedNCT03135951

Spectrum Pharmaceuticals, IncBreast Cancer, Pharmacokinetics

Start: 2017-05-11End: 2018-05-18Updated: 2020-11-13

Phase 2

Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

CompletedNCT01724866

Spectrum Pharmaceuticals, IncNeutropenia

Start: 2013-03-25End: 2014-08-12Updated: 2022-04-15

Phase 3

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)

CompletedNCT02643420

Spectrum Pharmaceuticals, IncBreast Cancer, Neutropenia

Start: 2016-01-19End: 2018-10-31Updated: 2022-03-02

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

CompletedNCT02953340

Spectrum Pharmaceuticals, IncBreast Cancer, Neutropenia

Start: 2017-05-10End: 2019-05-06Updated: 2022-03-02

Related Papers

Abstract P4-10-22: Eflapegrastim, a long-acting GCSF, administered the same day as chemotherapy in patients with early-stage breast cancer: Results from a multicenter, open-label, study

Clinical Cancer Research2025-06-13

Eflapegrastim, a novel, long-acting GCSF for reducing chemotherapy-induced neutropenia: Integrated results from two phase III trials in breast cancer patients.

Journal of Clinical Oncology2019-11-01

Eflapegrastim, a novel and potent long-acting GCSF for reducing chemotherapy-induced neutropenia: Integrated results from two phase III trials in breast cancer patients.

Journal of Clinical Oncology2019-05-20

Safety and efficacy of eflapegrastim in reducing severe neutropenia in patients treated with myelosuppressive chemotherapy in a phase 3 randomized controlled trial compared to pegfilgrastim (ADVANCE trial).

Journal of Clinical Oncology2018-05-202 citations