Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT01648322) | Clinical Trial Compass
CompletedPhase 2
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
United States232 participantsStarted 2012-06
Plain-language summary
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.
Who can participate
Age range18 Years – 74 Years
SexFEMALE
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Inclusion Criteria:
* Show evidence of a signed (personally or by a legally acceptable representative) and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
* Females ≥ 18 years of age.
* Diagnosed with Stage I-IV breast cancer.
* Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 mg/m2, respectively).
* ECOG Performance status of ≤ 2.
* 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 are 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 enrollme…
What they're measuring
1
Duration of Moderate Neurtopenia Post First Chemotherapy Administration
Timeframe: The first of 4, 21 Day Chemotherapy Cycles