CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 232 enrolled
Drug / intervention
F-627 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01648322
NCT01648322Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

EVIVE Biotechnology·interventional·Posted Jul 24, 2012·Updated Oct 3, 2018

In Brief

A Phase 2 clinical trial evaluating F-627 and Neulasta® (pegfilgrastim) for Breast Cancer and Neutropenia. Completed, enrolled 232 participants across 1 site.

Detailed Summary

This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Neutropenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartJun 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 13.9 years ago

Interventions

F-627drug

subcutaneous injection given 1 per chemotherapy.

Neulasta® (pegfilgrastim)drug

Single dose injection given once per chemotherapy cycle.