Phase 2
N=148
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT01724866 ↗Enrolled (actual)
148
Serious AEs
12.8%
Results posted
Apr 2022
Primary outcome: Primary: Duration of Severe Neutropenia (DSN) in Cycle 1 — 1.03; 0.44; 0.03; 0.31 days — p=0.296
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPI-2012 (Drug); Pegfilgrastim (Drug); Docetaxel (Drug); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectrum Pharmaceuticals, Inc
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Neutropenia (DSN) in Cycle 1 |
1.03; 0.44; 0.03; 0.31 | 0.296 |
| SECONDARY Duration of DSN in Cycle 2 |
0.46; 0.12; 0.03; 0.08 | 0.001 sig |
| SECONDARY Duration of DSN in Cycle 3 |
0.45; 0.16; 0.15; 0.14 | 0.002 sig |
| SECONDARY Duration of DSN in Cycle 4 |
1.05; 0.19; 0.09; 0.11 | 0.781 |
| SECONDARY Time to ANC Recovery in Cycle 1 |
10.0; 8.5; 8.0; 9.0 | 0.002 sig |
| SECONDARY Time to ANC Recovery in Cycle 2 |
11.0; 9.5; 10.0; 10.0 | 0.672 |
| SECONDARY Time to ANC Recovery in Cycle 3 |
10.0; 9.5; 9.0; 10.0 | 0.618 |
| SECONDARY Time to ANC Recovery in Cycle 4 |
11.0; 10.0; 10.0; 10.0 | 0.009 sig |
| SECONDARY Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1 |
1.5; 4.0; 7.2; 3.2 | 0.008 sig |
| SECONDARY Absolute ANC Nadir Overtime in Cycle 2 |
2.0; 3.9; 6.8; 3.3 | 0.005 sig |
| SECONDARY Absolute ANC Nadir Overtime in Cycle 3 |
2.3; 4.4; 6.1; 3.5 | 0.015 sig |
| SECONDARY Absolute ANC Nadir Overtime in Cycle 4 |
2.1; 4.1; 4.8; 2.7 | 0.106 |
| SECONDARY Depth of ANC Nadir in Cycle 1 |
0.8; 3.0; 6.2; 3.0 | — |
| SECONDARY Depth of ANC Nadir in Cycle 2 |
1.3; 3.3; 4.8; 2.9 | — |
| SECONDARY Depth of ANC Nadir in Cycle 3 |
1.9; 3.4; 4.1; 3.5 | — |
| SECONDARY Depth of ANC Nadir in Cycle 4 |
8.0; 4.2; 4.2; 2.4 | — |
| SECONDARY Time to ANC Nadir in Cycle 1 |
8.0; 7.0; 7.0; 7.5 | — |
| SECONDARY Time to ANC Nadir in Cycle 2 |
8.0; 7.0; 8.0; 8.0 | — |
| SECONDARY Time to ANC Nadir in Cycle 3 |
8.0; 7.0; 8.0; 8.0 | — |
| SECONDARY Time to ANC Nadir in Cycle 4 |
8.0; 8.0; 8.0; 8.0 | — |
| SECONDARY Percentage of Participants With Febrile Neutropenia (FN) Across All Cycles From Cycle 1 to Cycle 4 |
7.7; 2.8; 2.8; 5.6 | 1.000 |
| SECONDARY Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Other Serious Adverse Events (SAEs), and Other AEs Leading to Discontinuation From Study Therapy, and Worst Grade Laboratory Abnormalities |
24; 12; 13; 12; 0; 0 | — |
| SECONDARY Percentage of Participants With Hospitalization Across All Cycles From Cycle 1 to Cycle 4 |
7.7; 8.3; 2.8; 13.9 | 0.469 |
| SECONDARY Number of Participants With Positive Antibodies for SPI-2012 |
0; 0; 2 | — |
| SECONDARY Time to Reach Maximum Concentration of SPI-2012 (Tmax) |
58.7; 9.00; 24.0 | — |
| SECONDARY Maximum Concentration of SPI-2012 (Cmax) |
7.00; 247; 299 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time Zero to 312 Hours Post-Dose (AUC0-312) |
16000; 22900 | — |
| SECONDARY Half-life of SPI-2012 (t1/2) |
81.0; 31.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01724866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.