Clinical Trial: A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center, Randomized, Open-label, Active-controlled, Dose Finding Study to Evaluate the Efficacy and Safety of F-627 Compared to Filgrastim in Women With Breast Cancer Receiveing Myelotoxic Chem

Brief Summary:

This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy.

Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.


Detailed Summary:

This phase II study was conducted at 16 clinical centers in China and planned to enroll 150 women with breast cancer who will receive chemotherapy that includes up to 4 cycles of epirubicin and cyclophosphamide, 100 mg/m2 and 600 mg/m2, respectively. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio on Day 1 of the study. Patients will remain on their randomized study drug dose and regimen for each of the following 3 chemotherapy cycles. The chemotherapy to be administered for chemotherapy cycles 2-4 should be the same therapy administered to the subject on Day1.

Chemotherapy will be administrated through intravenous IV) injection on Day 1 of each 21-day cycle and be repeated every 3 weeks for up to four cycles unless a dose delay is necessary. Approximately 48 hours after chemotherapy completion in cycle (day 3 of the cycle), patients will either receive a subcutaneous (SC) injection of F-627 (either 10 mg/dose or 20 mg/dose) or 5 μg/kg/dose filgrastim used up to two weeks or stopped while ANC more than 5 × 109/L.

To track ANC concentration post chemotherapy, subjects returned to their study site for blood draws either daily (Cycle 1) or 3 times per week (every other day; Cycles 2-4) until ANC levels reached ≥2.0 × 109/L, post-nadir, and then every 3 days until the next chemotherapy cycle.

All subjects returned for an End of Study visit approximately 3 weeks after their final study drug administration (Study Day 84) and had a follow-up phone call 30 days after the last study drug.


Sponsor: Generon (Shanghai) Corporation Ltd.

Current Primary Outcome: The duration of moderate or severe (grade 3 and 4, respectively) neutropenia post chemotherapy as measure of efficacy of F-627 compared to Filgrastim in female patients wiht breast cance receiving adjuvant chemotherapy. [ Time Frame: In first of 4 cycles (21 days for each cycle) 84 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidence rates of Grade 3 and Grade 4 neutropenia (ANC < 1.0 × 109/L and < 0.5 × 109/L, respectively) for all chemotherapy cycles. [ Time Frame: up to 4 cycles (84 days) ]
  • The duration in days of Grade 3 and Grade 4 neutropenia (ANC <1.0 × 109/L and ANC <0.5 × 109/L, respectively) for cycle 2 to 4. [ Time Frame: cycle 2-4 (63 days) ]
  • The incidence rates of febrile neutropenia (FN; defined as a decrease in neutrophils associated with fever) for each chemotherapy cycle. [ Time Frame: Up to 4 cycles (84 days) ]
  • The depth of the ANC nadir for chemotherapy Cycles 1 to 4. [ Time Frame: Up to 4 cycles (84 days) ]
  • Number of participants with adverse events, changes from baseline of labarotory values as measure of safety of F-627 comparated to Filgrastim in female patients wiht breast cance receiving chemotherapy. [ Time Frame: Up to 4 cycles (84 days) ]


Original Secondary Outcome: Same as current

Information By: Generon (Shanghai) Corporation Ltd.

Dates:
Date Received: August 10, 2015
Date Started: May 2014
Date Completion: December 2015
Last Updated: August 11, 2015
Last Verified: August 2015