Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Breast Neoplasms

Neutropenia

Breast Diseases

Skin Diseases

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Docetaxel

This dose of F-627 given only to subjects that are to have TC chemotherapy.

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

Given to subjects receiving TC or TAC chemotherapy.

subcutaneous injection given 1 per chemotherapy.

F-627

Single dose injection given once per chemotherapy cycle.

Neulasta® (pegfilgrastim)

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.

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.

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

Number of days In which the patient has had an absolute neutrophil count (ANC) Level \< 2.0 x 10\^9/L after first cycle of chemotherapy

Number of days In which the patient has had an ANC \< 1.0 × 10\^9/L (Grade 3) or ANC \< .5 × 10\^9/L (Grade 4) post each chemotherapy

The incidence rate of febrile neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.

Number of says in which the patient has had an ANC Level ANC \< 1.5 × 109/L) post each chemotherapy

The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded; recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10\^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration). Each chemotherapy cycle is expected to last 21 days.

The incidence rate of mild, moderate and sever neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.

The depth of ANC nadir for each cycle is defined as the minimal ANC value for a subject in each chemotherapy cycle. The depth of the ANC nadir for each arm of the study will be recorded for 4 chemotherapy cycles.

EVIVE Biotechnology

The NCI CTCAE v4.0 grading system was used in AE reporting to provide a standard language to describe toxicities, to facilitate tabulation and analysis of the data, and to facilitate the assessment of the clinical significance of all AEs. AEs were to be recorded and graded 1 to 5 according to the CTCAE grades provided below:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe and undesirable AE Grade 4 Life-threatening or disabling AE Grade 5 Death

This dose of F-627 given only to subjects that are to have TC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

80 µg/kg/Dose of F-627

This dose of F-627 given to subjects receiving TC or TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

240 µg/kg/Dose of F-627

320 µg/kg/Dose of F-627

Neulasta fixed dose of 6mg given to subjects receiving TC or TAC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle.

Neulasta® (Pegfilgrastim)

Given to subjects receiving TC or TAC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle.

Total

Age, Continuous

Sex: Female, Male

weight

Height

Grade 0

Grade 1

Grade 2

The ECOG Scale of Performance Status describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).

GRADE 0. Fully active

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all self care but unable to carry out any work activities

A subject's ECOG grade is determined by the study doctor based on the established criteria listed above.

Grade 0 is best. Grade 2 is worse than Grade 1.

ECOG status

Cancer Stage at screen

Chief Medical Officer

80 µg/kg/Dose of F-627(TC)

240 µg/kg/Dose of F-627 (TC)

320 µg/kg/Dose of F-627 (TC)

Neulasta® (Pegfilgrastim) (TC)

This dose of F-627 given to subjects receiving TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

240 µg/kg/Dose of F-627 (TAC)

320 µg/kg/Dose of F-627 (TAC)

Neulasta fixed dose of 6mg given to subjects receiving TAC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

Neulasta® (Pegfilgrastim) (TAC)

Duration of Moderate Neurtopenia Post First Chemotherapy Administration

This dose of F-627 given to subjects receiving TC chemotherapy.

F-627: subcutaneous injection given 1 per chemotherapy.

Given to subjects receiving TC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle.

240 µg/kg/Dose of F-627- TAC

320 µg/kg/Dose of F-627 -TAC

Given to subjects receiving TAC chemotherapy.

Neulasta® (pegfilgrastim): Single dose injection given once per chemotherapy cycle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy	NCT01648322	Breast Cancer Neutropenia	F-627 Neulasta® (pegf...	18 Years - 74 Years	EVIVE Biotechnology
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy	NCT01648322	Breast Cancer Neutropenia	F-627 Neulasta® (pegf...	18 Years - 74 Years	EVIVE Biotechnology

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