Clinical Trial: A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

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

Official Title: A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of F-627 as Prophylaxis Therapy to TAC Chemotherapy in Women With Breast Cancer

Brief Summary:

This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.

The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles.


Detailed Summary:

This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627 once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.

This study was conducted at two centers in China and enrolled 15 patients with breast cancer receiving TAC chemotherapy (docetaxel, doxorubicin and cyclophosphamide). The patients received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours after chemotherapy) each cycle for up to 6 cycles. Patients will remain on study drug dose for each of the following 6 chemotherapy cycles.

Patients will remain on study drug dose for each of the following 6 chemotherapy cycles. The blood sampling will be collected for F-627 serum concentration analysis in cycle of 1 and 3.


Sponsor: Generon (Shanghai) Corporation Ltd.

Current Primary Outcome: Number of participants with adverse events/abnormal laboratory value as measure of safety and tolerability of rh G-CSF Fc fusion protein (F-627) in female patients wiht breast cance receiving adjuvant chemotherapy. [ Time Frame: Up to 6 cycles (about 126 days) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Parameter of Peak Plasma Concentration as a measure of pharmacokinetics profile of F-627. [ Time Frame: Cycle 1 and cycle 3 (each cycle was about 21 days) ]
  • Parameter of Area Under Plasma Concentration versus Time Curve as a measure of pharmacokinetics profile of F-627. [ Time Frame: Cycle 1 and cycle 3 (each cycle was about 21 days) ]
  • Parameter of Clearance as a measure of pharmacokinetics profile of F-627. [ Time Frame: Cycle 1 and cycle 3 (each cycle was about 21 days) ]
  • Absolute Neutrophil Count changes over time as measure of pharmacodynamics of F-627. [ Time Frame: Up to 6 cycles (about 126 days) ]


Original Secondary Outcome: Same as current

Information By: Generon (Shanghai) Corporation Ltd.

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