A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Overview
- Phase
- Phase 3
- Intervention
- F-627
- Conditions
- Breast Cancer
- Sponsor
- EVIVE Biotechnology
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.
Detailed Description
This is a randomized, multi-center, single dose, double-blind, placebo controlled phase III study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin(doxorubicin)). F-627 is designed to treat neutropenia, an abnormally low number of neutrophils (a type of white blood cell) in the blood. Neutropenia is often seen in cancer patients receiving myelotoxic chemotherapy. The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo. F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment (up to 4 cycles). Patients randomized to placebo arm will receive F-627 except in cycle 1. The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC \< 0.5 x 10\^9/L) observed in chemotherapy cycle 1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- •Females ≥ 18 years of age and \< 75 years of age.
- •Diagnosed with Stage II-IV breast cancer.
- •Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
- •ECOG Performance status of ≤
- •White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
- •Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
- •All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.
Exclusion Criteria
- •Subject is \<18 or ≥ 75 years of age.
- •Disease progression has occurred while receiving a taxane regimen.
- •Subject has undergone radiation therapy within 4 weeks of enrollment.
- •Subject has undergone bone marrow or stem-cell transplantation.
- •Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
- •Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
- •Subject has had chemotherapy within 365 days of screening.
- •Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
- •History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
- •Unwillingness to participate in the study.
Arms & Interventions
F-627
F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
Intervention: F-627
Placebo
Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Intervention: F-627
Placebo
Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
Intervention: Placebo
Outcomes
Primary Outcomes
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
Time Frame: The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks
Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10\^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC \<0.5x10\^9/L) in this cycle is the primary efficacy endpoint.
Secondary Outcomes
- The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.(Over all 4 cycles, about 12 weeks)
- The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.(4 chemotherapy cycles, about 12 weeks)
- Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles(4 chemotherapy cycles, about 12 weeks)
- Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.(4 chemotherapy cycles, about 12 weeks)
- The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.(4 chemotherapy cycles, about 12 weeks)
- The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.(4 chemotherapy cycles, about 12 weeks)
- Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.(4 chemotherapy cycles, about 12 weeks)
- Number of Participants With Use of Antibiotics and Pain Medications(4 chemotherapy cycles, about 12 weeks)