EUCTR2016-001965-98-NLActive, not recruitingPhase 1
A randomized and open-label dose-finding, phase 2, efficacy, safety, and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO™ versus pegfilgrastim (Neulasta®) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Prolong Pharmaceuticals, LLC
- Enrollment
- 65
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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 < 2.5 x ULN)
- •9. Women of childbearing potential with a negative serum pregnancy
- •test and using a highly effective method of birth control (i.e., one that
- •results in a less than 1% per year failure rate when used consistently
- •and correctly, such as intrauterine devices (IUDs)). Periodic abstinence
- •is not an acceptable contraceptive method during the study period.
- •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 65
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
Investigators
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