Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia MedDRA version: 18.1 Level: LLT Classification code 10021456 Term: Immunodeficiency secondary to oncology chemotherapy System Organ Class: 100000004870
Conditions
Interventions
Product Name: HSP-130
Product Code: HSP-130
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: N/A
CAS Number: 208265-92-3
Current Sponsor code: HSP-130
Other descr
Sponsors
Hospira, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics Committee (IEC) prior to any study related activities 2. Females = 18 years 3. Histologically confirmed and documented invasive breast cancer 4. Breast cancer without evidence of distant metastases (non-Stage 4) based on staging work-up 5. Chemotherapy naïve, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide based regimen, i.e., TAC as background chemotherapy 6. Zubrod/WHO/ECOG performance status = 2 7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by: a. Hemoglobin = 10 mg/dL b. ANC = 1.5 x 109/L c. Platelet count of = 100 x 109/L d. Total bilirubin = 2 mg/dL e. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 3 x the upper limit of normal (ULN) of the reference lab f. Serum creatinine of = 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of = 60 mg/min 8. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. 9. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. Previous granulocyte colony stimulating factor (G CSF) exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM CSF), or any other branded or biosimilar G CSF 2. Prior autologous stem cell harvest of any type 3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to Escherichia coli (E. coli) derived proteins, filgrastim, other G CSFs, or pegylated agents 4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin 5. Chemotherapy other than that included in this study (i.e., taxane/cyclophosphamide-based regimen, i.e., TAC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP 130, prior bone marrow or stem cell transplantation, or malignancy within 5 years 6. Known HER2+ (overexpressing breast cancer) 7. Known triple negative (estrogen receptor negative, progesterone receptor negative and HER2 negative) breast cancer 8. Medical conditions including but not limited to: Known sickle cell disease; known severe persistent drug induced myelosuppression; severe uncontrolled cardiac disease; any malignancy other than breast with the exception of adequately treated squamous or basal cell carcinoma or the skin or cervical carcinoma in situ within 5 years; pregnancy or lactation; received live, live attenuated, or non live vaccine within 4 weeks 9. Current or recent treatment (within 30 days before the first administration of the HSP 130) with any other Investigational Medicinal Product 10. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP 130, or patient is high risk for treatment complication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Cycle 0: Pharmacodynamic sampling for absolute neutrophil count (ANC), CD34+ count will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose Cycles 1 - 4 Pharmacodynamic sampling for absolute neutrophil count (ANC) will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only ;Secondary Objective: Cycle 0: To characterize the pharmacokinetics (PK) of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC injection without background chemotherapy. To characterize the safety of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC dose without background chemotherapy. Cycles 1 - 4: To characterize the PD response of ANC to HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses. To characterize the PK of HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses. To characterize the safety of HSP 130 over a range of doses when administered as single and multiple SC doses. ;Primary end point(s): Pharmacodynamic Endpoints: Cycle 0: • Primary Variable: Area under the effect curve for ANC (AUECANC) • Secondary Variables: Maximum effect for ANC (ANC_Emax), time of maximum effect for ANC (ANC Tmax), area under the effect curve for CD34+ (AUECCD34+), maximum effect for CD34+ count (CD34+_Emax), time of maximum effect for CD34+ count (CD34+ Tmax) Cycles 1 - 4: • Primary Variable: Duration of severe neutropenia (DSN). DSN is defined as days with grade 4 neutropenia (ANC 38.5°C for > 1 hour with ANC < 1.0 x 109/L, incidence of severe neutropenia (grade 4, ANC < 0.5 x 109/L) and time to ANC recovery (the first day with ANC = 2.0 x 109/L after any day with ANC < 2.0 x 109/L) in Cycle 1 and Cycle 4 ;Main Objective: Cycle 0: To | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic Endpoints: Cycle 0: •Primary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to time infinity (AUC0 8) and the maximum observed serum HSP 130 concentration (Cmax) •Secondary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to the time of last measurable concentration (AUC0 t), the time of maximum serum HSP 130 concentration (Tmax), elimination half life (t1/2), elimination rate constant (?z), and apparent clearance (CL) Cycles 1–4: •Primary Variables: AUC 0-t and Cmax •Secondary Variables: AUC 0-8, Tmax, t1/2, ?z, and CL ;Timepoint(s) of evaluation of this end point: Cycle 0: Pharmacokinetic sampling will be collected within 1 hour prior to dose at Day 1, and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose Cycles 1 - 4 Pharmacokinetic sampling will be collected within 1 hour prior to dose and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only | — |
Countries
Hungary, Spain
Contacts
Public ContactEuropean Project Operations
Biorasi LLC
Outcome results
None listed