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
- chemotherapy-induced neutropenia (CIN)MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001965-98-NL
- Lead Sponsor
- Prolong Pharmaceuticals, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method