chemotherapy-induced neutropenia (CIN) MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851
Conditions
Interventions
Product Name: ANF-RHO
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not assigned
CAS Number: Not assigned
Current Spo
Sponsors
Prolong Pharmaceuticals, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult female patients, 18 years of age or older 2. Signed and dated written consent/assent by the patient or legally authorized representative 3. Histologically confirmed non-metastatic breast cancer 4. ECOG performance status = 2 5. Must have received FE100C (fluorouracil/epirubicin (100)/cyclophosphamide) (3 cycles) prior to study entry 6. Scheduled to receive and anticipated to complete the following chemotherapy regimen after FE100C: 3 Docetaxel chemotherapy cycles 7. White blood cell (WBC) = 3 × 109/L; ANC = 2.0 × 109/L; platelet count = 100 × 109/L; and hemoglobin = 10 g/dL (6.2 mmol/L) 8. Adequate cardiac function and adequate hepatic function (e.g., liver transaminases =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be enrolled if they meet any of the following criteria: 1. Known hypersensitivity to E.coli derived products or polyethylene glycol 2. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated =5 years ago with curative intent 3. Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease 4. Clinical diagnosis or history of chronic infection such as hepatitis B virus(HBV), hepatitis C Virus (HCV) or Human immunodeficiency virus(HIV) or history of tuberculosis 5. Subjects experiencing Febrile Neutropenia during any of the three chemotherapy cycles with FE100C 6. Treatment with systemically active antibiotics within 72 hours before chemotherapy 7. Chronic use of oral corticosteroids 8. Participation in a clinical pharmacological trial within 30 days before randomization 9. Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening 10. Documented alcohol abuse within 30 days prior to screening. 11. Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol 12. Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test 13. Other serious medical condition that would prevent individual from receiving protocol treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the Absolute Neutrophil Count [ANC = PMN (polynorphonuclear leukocytes) +Bands] grade decline (neutropenia as assessed by CTCAE v5.0) observed after escalating doses of ANF-RHO and to assess the incidence (in Part B) and incidence and duration (in Part C) of neutropenia grade 3 (ANC < 1.0×109/L - = 0.5×109/L) and grade 4 (ANC < 0.5×109/L) in the first chemotherapy docetaxel cycle (21-day cycle). ; Secondary Objective: • Assess efficacy of escalating doses of ANF-RHO (Part B) and v Neulasta (Part C) on the: - incidence & duration of neutropenia = G1 in the first chemo cycle (21d with Docetaxel). - incidence & duration of G3 and G4 neutropenia during all Docetaxel chemo cycles. - incidence and duration of febrile neutropenia in breast cancer pts undergoing 3 cycles of high-risk myelosuppressive chemo with Docetaxel. • Evaluate PK of escalating doses of ANF-RHO in breast cancer pts undergoing 3 cycles of high-risk myelosuppressive chemo with Docetaxel (Parts B & C) • Evaluate immunogenicity of escalating doses of ANF-RHO in breast cancer pts undergoing 3 cycles of high-risk myelosuppressive chemo with Docetaxel (Parts B & C) • Evaluate safety of subcutaneous injections of ANF-RHO in breast cancer pts undergoing 3 cycles of high-risk myelosuppressive chemo with Docetaxel, including incidence & severity of bone pain, leukocytosis and febrile neutropenia (Part B) compared to Neulasta (Part C) ; Primary end point(s): •Incidence (in Part B) and incidence and duration (in Part C) of neutropenia grade 3 (ANC < 1.0×109/L - = 0.5×109/L) or grade 4 (ANC < 0.5×109/L) in the first cycle of Docetaxel chemotherapy, following 3 standard care cycles of FE100C, with escalating doses of ANF-RHO ;Timepoin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence and duration of neutropenia grade 1 or worse (ANC = 2.0×109/L) in the first cycle of chemotherapy (Docetaxel) with escalating doses of ANF-RHO (Part B) and recommended ANF-RHO dose versus Neulasta (Part C) • Incidence and duration of Grade 3 (ANC < 1.0×109/L - = 0.5×109/L) and grade 4 neutropenia (ANC < 0.5×109/L) during all Docetaxel chemotherapy cycles (21-day cycle Docetaxel) with escalating doses of ANF-RHO (Part B) and recommended ANF-RHO dose versus Neulasta (Part C) • Incidence and duration of febrile neutropenia defined as peak temperature = 38.5°C (or = 38.0°C for two readings over two hours) and ANC < 0.5×109/L, during all Docetaxel chemotherapy cycles (Parts B and C)** • Incidence and duration of infection and infection-related events (e.g., antibiotic use, need for hospitalization, etc.) during all Docetaxel chemotherapy cycles (Parts B and C)** • Incidence and duration of moderate (ANC = 50×109/L) and severe (ANC = 100×109/L) leukocytosis during all chemotherapy cycles** • Clinically meaningful changes in vital signs during all Docetaxel chemotherapy cycles (Parts B and C)** • Incidence, duration, severity and site of bone pain, determined by a numerical rating scale, as well as other reported adverse events (Parts B and C)** • Pharmacokinetic profile of ANF-RHO and Neulasta (Parts B and C)** • Incidence of anti drug antibodies (ADA) to ANF-RHO and Neulasta (Parts B and C)** **These secondary objectives were also assessed in Part A (cohort completed; ANF-RHO 10 µg/kg vs Neulasta). Part A had 6 chemotherapy cycles (3 cycles of FE100C and 3 cycles of Docetaxel). ;Timepoint(s) of evaluation of this end point: 68 days | — |
Countries
Netherlands
Contacts
Public ContactPaul MANLEY
Prolong Pharmaceuticals, LLC
Outcome results
None listed