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

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.

Conditions

• Neutropenia

Interventions

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.

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Huaxi Hospital

  collaborator OTHER

• EVIVE Biotechnology

  lead INDUSTRY

Principal Investigators

• Jin Li, Professor · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-03

Primary Completion

2015-09-20

Completion

2015-12-22

Countries

• China

Study Locations