Clinical trial · Interventional
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (HM10460A) or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen
NCT01724866CI-TRIAL-00057845completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| SPI-2012 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)
- description
- 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.
- interventionNames
- Drug: SPI-2012
- Drug: Docetaxel
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy * Candidate for docetaxel and cyclophosphamide chemotherapy * Female or male at least 18 years of age * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Absolute neutrophil count (ANC) ≥ 1.5×109/L * Platelet count ≥ 100 x 10\^9/L * Creatinine ≤ 1.5 x upper limit of normal (ULN) * Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L). * Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN * Hemoglobin \> 9 g/dL * Alkaline phosphatase ≤ 1.5 x ULN Exclusion Criteria: * Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered * Known Human Immunodeficiency Virus (HIV) infection * Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease * Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment * Prior bone marrow or stem cell transplant * Prolonged exposure to glucocorticosteroids and immunosuppressive agents
References
Publications (1)
- DERIVEDVacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23. PMID 29573207