NCT02521441

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

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 Receiving Myelotoxic Chemotherapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: EVIVE Biotechnology · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Neutropenia

Interventions

Type	Name	Description
BIOLOGICAL	F-627	F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.
BIOLOGICAL	Filgrastim	Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.

Timeline

• Start date: 2014-07-03
• Primary completion: 2015-09-20
• Completion: 2015-12-22
• First posted: 2015-08-13
• Last updated: 2018-02-23

Locations

1 site across 1 country: China