NCT01648322

Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: EVIVE Biotechnology · Industry
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, multi-center, dose finding, open label, positive controlled Phase II study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta® (pegfilgrastim) in women with breast cancer who are receiving myelotoxic chemotherapy (TC: docetaxel + cyclophosphamide or TAC: docetaxel + doxorubicin + cyclophosphamide). The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study will be defined by the duration of moderate neutropenia; the number of days in which the patient has had an absolute neutrophil count (ANC) \< 1.0 × 10\^9/L during the first cycle of their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to be tested for subjects receiving TC chemotherapy are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose. For subjects receiving TAC chemotherapy, only 240 µg/kg/dose and 320 µg/kg/dose are to be tested.

Conditions

• Breast Cancer
• Neutropenia

Interventions

Type	Name	Description
DRUG	F-627	subcutaneous injection given 1 per chemotherapy.
DRUG	Neulasta® (pegfilgrastim)	Single dose injection given once per chemotherapy cycle.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-07-24
• Last updated: 2018-10-03
• Results posted: 2018-03-20

Locations

1 site across 1 country: United States