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

NCT02872103 | Completed Phase 3 Results

• 1 other identifier: GC-627-04
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.

Conditions

Breast Cancer; Neutropenia

Outcome Measures

Primary Outcomes (1)

• The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo

  Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10\^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC \<0.5x10\^9/L) in this cycle is the primary efficacy endpoint.

  The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks

Secondary Outcomes (8)

• The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.

  Over all 4 cycles, about 12 weeks

• The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.

  4 chemotherapy cycles, about 12 weeks

• Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles

  4 chemotherapy cycles, about 12 weeks

• Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.

  4 chemotherapy cycles, about 12 weeks

• The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.

  4 chemotherapy cycles, about 12 weeks

Study Arms (2)

F-627

EXPERIMENTAL

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

Drug: F-627

Placebo

PLACEBO COMPARATOR

Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.

Drug: F-627; Drug: Placebo

Interventions

F-627 DRUG

F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study

F-627; Placebo

Placebo DRUG

Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.

Placebo

Eligibility Criteria

• Age: 18 Years - 74 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 and \< 75 years of age.
• Diagnosed with Stage II-IV breast cancer.
• Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
• ECOG Performance status of ≤ 2.
• White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
• Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x 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 or ≥ 75 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 365 days of screening.
• Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, 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.
• Any condition, which can cause splenomegaly.
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
• ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.

Sponsors & Collaborators

• EVIVE Biotechnology: lead

Study Sites (1)

Covance

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

• Glaspy J, Bondarenko I, Burdaeva O, Chen J, Rutty D, Li R, Wang S, Hou Q, Li S. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. Support Care Cancer. 2023 Dec 16;32(1):34. doi: 10.1007/s00520-023-08176-6.

  PMID: 38103088 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

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: Jianmin Chen
• Organization: Generon

jianmin_chen@generonbiomed.com

7327100262

Study Officials

• Kevin F Dreyer

  EVIVE Biotechnology

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: May 5, 2021
• Results First Posted: March 26, 2019

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)