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Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

NCT02527746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-23

Study results available
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Summary

A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.

Conditions

Interventions

DRUG

F-627

F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.

DRUG

EC regimen

Epirubicin 100 mg/m\^2 (in vein) and Cyclophosphamide 600 mg/m\^2 (in vein) on Day 1 of each cycle for 4 cycles.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • EVIVE Biotechnology

    lead INDUSTRY

Principal Investigators

  • Junning Cao, Professor · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527746 on ClinicalTrials.gov