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

NCT01648322 | Completed Phase 2 Results

• 1 other identifier: GC-627-02
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Neutropenia

Keywords

Breast Cancer; Taxotere Chemotherapy; Neulasta; efficacy and safety; single cycle doses of F-627; pegfilgrastim

Outcome Measures

Primary Outcomes (1)

• Duration of Moderate Neurtopenia Post First Chemotherapy Administration

  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

  The first of 4, 21 Day Chemotherapy Cycles

Secondary Outcomes (6)

• Duration in Days of Grade 3 and Grade 4 Neutropenia for All 4 Chemotherapy Cycles.

  Measured for each of the 4, 21 day chemotherapy cycles.

• The Incidence Rate of Febrile Neutropenia

  Measured for each of the 4, 21 day chemotherapy cycles.

• The Duration in Days of Total Grade 2-4 Neutropenia

  Measured for each of the 4, 21 day chemotherapy cycles.

• The Time to ANC Recovery Post Nadir

  Measured for each of the 4, 21 day chemotherapy cycles.

• The Incidence Rates of Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles

  Measured for each of the 4, 21 day chemotherapy cycles.

Study Arms (4)

80 µg/kg/dose of F-627

EXPERIMENTAL

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

Drug: F-627

240 µg/kg/dose of F-627

EXPERIMENTAL

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

Drug: F-627

320 µg/kg/dose of F-627

EXPERIMENTAL

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

Drug: F-627

Neulasta® (pegfilgrastim)

ACTIVE COMPARATOR

Given to subjects receiving TC or TAC chemotherapy.

Drug: Neulasta® (pegfilgrastim)

Interventions

F-627 DRUG

subcutaneous injection given 1 per chemotherapy.

240 µg/kg/dose of F-627; 320 µg/kg/dose of F-627; 80 µg/kg/dose of F-627

Neulasta® (pegfilgrastim) DRUG

Single dose injection given once per chemotherapy cycle.

Neulasta® (pegfilgrastim)

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 signed (personally or by a legally acceptable representative) 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-IV breast cancer.
• Subject is scheduled to undergo 4 cycles of TC or TAC chemotherapy (Taxotere®, doxorubicin and cyclophosphamide, 75, 50 and 600 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 are 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.
• Subjects that have used G-CSF within 6 weeks of the screening period are also 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 \> 2.5 upper limit of normal.

Sponsors & Collaborators

• EVIVE Biotechnology: lead

Study Sites (1)

Community Hospital of Anderson

Anderson, Indiana, 46011, United States

Location

Related Publications (1)

• Glaspy J, Bondarenko I, Krasnozhon D, Rutty D, Chen J, Fu Y, Wang S, Hou Q, Li S. Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial. Support Care Cancer. 2024 Jan 9;32(2):91. doi: 10.1007/s00520-023-08260-x.

  PMID: 38194162 DERIVED

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: Chief Medical Officer
• Organization: Generon (shanghai) corporation

tangt@generonbiomed.com

8621-61760866

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: July 24, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 3, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)