Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

NCT03252431 | Completed Phase 3 Results FDA Drug

• 1 other identifier: GC-627-05
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.

Conditions

Breast Cancer; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1

  Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.

  The first of 4, 21-day chemotherapy cycles (average 3 weeks)

Secondary Outcomes (6)

• Duration in Days of Use of Intravenous Antibiotic

  across all 4 chemotherapy cycles (average 84 days)

• Duration in Days of Hospitalization

  across all 4 chemotherapy cycles (average 84 days)

• The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1

  The first of 4, 21-day chemotherapy cycles (average 3 weeks)

• The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.

  across all 4 chemotherapy cycles (average 84 days)

• The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.

  across all 4 chemotherapy cycles (average 84 days)

Study Arms (2)

F-627

EXPERIMENTAL

F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.

Drug: F-627

Neulasta

ACTIVE COMPARATOR

6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles

Drug: Neulasta

Interventions

F-627 DRUG

single dose pre-filled syringe

F-627

Neulasta DRUG

single dose pre-filled syringe

Also known as: pegfilgrastim

Neulasta

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
• Females ≥18 years of age.
• Diagnosed with Stage I-III breast cancer.
• Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).
• ECOG Performance status of ≤2.
• WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L.
• Demonstrate adequate renal, hepatic, and cardiac function (liver function tests \[alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin\]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
• All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.

You may not qualify if:

• Subject is \<18 years of age.
• Disease progression has occurred while receiving a taxane regimen.
• Subject has undergone radiation therapy within 4 weeks of enrollment.
• Subject has undergone bone marrow or stem-cell transplantation.
• Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
• Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.
• Subject has had chemotherapy within 180 days of screening.
• Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test.
• History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
• Unwillingness to participate in the study.
• Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
• Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less.
• Any condition, which can cause splenomegaly.
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
• ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN.

Sponsors & Collaborators

• EVIVE Biotechnology: lead

Study Sites (1)

University of California Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC)

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Results Point of Contact

• Title: Christina Tay
• Organization: Generon/Evive Biotech

christina.tay@evivebiotech.com

1-908-540-0816

Study Officials

• John Glaspy, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: April 12, 2018
• Primary Completion: September 25, 2019
• Study Completion: March 5, 2020
• Last Updated: July 3, 2023
• Results First Posted: May 7, 2021

Record last verified: 2021-04

Locations

US (1)