Breast CancerPhase 2NCT01648322

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

A Phase 2 study testing F-627 and Neulasta® (pegfilgrastim) in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 74 years, women only
Conditions the study is for: Breast Cancer, Neutropenia
What is being tested?: F-627 and Neulasta® (pegfilgrastim)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 232 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Dec 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 21Show fewer

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.
Patients with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
Women who are pregnant or breast-feeding.
Patients known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
Patients with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
Subjects with Sickle Cell disease
Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

Community Hospital of Anderson
Anderson, Indiana, 46011

Other trials in United States

About this study

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

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.

Read the 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
Being tested: F-627, Neulasta® (pegfilgrastim)
Keywords: Breast Cancer, Taxotere Chemotherapy, Neulasta, efficacy and safety, single cycle doses of F-627, pegfilgrastim
Medical subject headings: Breast Neoplasms, Neutropenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

F-627Drug
subcutaneous injection given 1 per chemotherapy.
Neulasta® (pegfilgrastim)Drug
Single dose injection given once per chemotherapy cycle.

Study groups in NCT01648322
Study group	Role	What they receive
80 µg/kg/dose of F-627	Experimental	This dose of F-627 given only to subjects that are to have TC chemotherapy. Receives: Drug: F-627
240 µg/kg/dose of F-627	Experimental	This dose of F-627 given to subjects receiving TC or TAC chemotherapy. Receives: Drug: F-627
320 µg/kg/dose of F-627	Experimental	This dose of F-627 given to subjects receiving TC or TAC chemotherapy. Receives: Drug: F-627
Neulasta® (pegfilgrastim)	Active comparator	Given to subjects receiving TC or TAC chemotherapy. Receives: Drug: Neulasta® (pegfilgrastim)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
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
Measured: Measured for each of the 4, 21 day chemotherapy cycles.
The Incidence Rate of Febrile Neutropenia
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.
Measured: Measured for each of the 4, 21 day chemotherapy cycles.
The Duration in Days of Total Grade 2-4 Neutropenia
Number of says in which the patient has had an ANC Level ANC < 1.5 × 109/L) post each chemotherapy
Measured: Measured for each of the 4, 21 day chemotherapy cycles.
The Time to ANC Recovery Post Nadir
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.
Measured: 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
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.
Measured: Measured for each of the 4, 21 day chemotherapy cycles.
The Depth of the ANC Nadir for All Chemotherapy Cycles
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.
Measured: Measured for each of the 4, 21 day chemotherapy cycles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Dec 2014

First posted24 Jul 2012 (estimated)
Study startJun 2012
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 232 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01648322
Sponsor's protocol ID: GC-627-02
Status last verified: Oct 2018
First submitted: 27 Apr 2012
Last updated: 3 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 38194162

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
ClinicalTrials.gov ID: NCT01648322
Acronym / sponsor ID: GC-627-02
Conditions: Breast Cancer, Neutropenia
Keywords: Breast Cancer, Taxotere Chemotherapy, Neulasta, efficacy and safety, single cycle doses of F-627, pegfilgrastim
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 232 participants (actual)
Lead sponsor: EVIVE BiotechnologyIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 24 Jul 2012 (estimated)
Results: Posted 20 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
80 µg/kg/dose of F-627	Experimental	Drug: F-627This dose of F-627 given only to subjects that are to have TC chemotherapy.
240 µg/kg/dose of F-627	Experimental	Drug: F-627This dose of F-627 given to subjects receiving TC or TAC chemotherapy.
320 µg/kg/dose of F-627	Experimental	Drug: F-627This dose of F-627 given to subjects receiving TC or TAC chemotherapy.
Neulasta® (pegfilgrastim)	Active comparator	Drug: Neulasta® (pegfilgrastim)Given to subjects receiving TC or TAC chemotherapy.

Who may qualify

Ages: 18 to 74 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
F-627subcutaneous injection given 1 per chemotherapy.	Drug	240 µg/kg/dose of F-627, 320 µg/kg/dose of F-627, 80 µg/kg/dose of F-627
Neulasta® (pegfilgrastim)Single dose injection given once per chemotherapy cycle.	Drug	Neulasta® (pegfilgrastim)

Primary outcome

Duration of Moderate Neurtopenia Post First Chemotherapy Administration
Time frame: The first of 4, 21 Day Chemotherapy Cycles
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

6 secondary outcomes

Duration in Days of Grade 3 and Grade 4 Neutropenia for All 4 Chemotherapy Cycles.
Time frame: Measured for each of the 4, 21 day chemotherapy cycles.
The Incidence Rate of Febrile Neutropenia
Time frame: Measured for each of the 4, 21 day chemotherapy cycles.
The Duration in Days of Total Grade 2-4 Neutropenia
Time frame: Measured for each of the 4, 21 day chemotherapy cycles.
The Time to ANC Recovery Post Nadir
Time frame: 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
Time frame: Measured for each of the 4, 21 day chemotherapy cycles.
The Depth of the ANC Nadir for All Chemotherapy Cycles
Time frame: Measured for each of the 4, 21 day chemotherapy cycles

Results and safety

Results posted to the registry on 20 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
80 µg/kg/Dose of F-627	35	33
240 µg/kg/Dose of F-627	67	62
320 µg/kg/Dose of F-627	65	60
Neulasta® (Pegfilgrastim)	65	61

Primary outcome: Duration of Moderate Neurtopenia Post First Chemotherapy Administration

Time frame: The first of 4, 21 Day Chemotherapy Cycles. Mean (Standard Deviation). Unit: days

Measure	80 µg/kg/Dose of F-627(TC) n = 35	240 µg/kg/Dose of F-627 (TC) n = 37	320 µg/kg/Dose of F-627 (TC) n = 31	Neulasta® (Pegfilgrastim) (TC) n = 35	240 µg/kg/Dose of F-627 (TAC) n = 30	320 µg/kg/Dose of F-627 (TAC) n = 29	Neulasta® (Pegfilgrastim) (TAC) n = 30
Value	0.6 (1.26)	0.6 (1.01)	0.4 (0.75)	0.3 (0.56)	2.1 (1.58)	2.1 (1.46)	1.8 (1.28)

Population analysed: per protocol population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were to be followed up 30 days after the last study visit for identification of AEs. Subsequent to the 30 day AE follow-up, subjects who discontinued due to FN were to be followed up for an additional 30 days to identify further FN events or severe neutropenia (defined as ANC <0.5×109/L) with duration >2 days. Any Grade 3 or 4 AEs or SAEs were to be followed up until they had resolved or stabilized.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
80 µg/kg/Dose of F-627	0 of 35 (0%)	32 of 35 (91.4%)	Not reported
240 µg/kg/Dose of F-627	1 of 67 (1.5%)	63 of 67 (94%)	Not reported
320 µg/kg/Dose of F-627	1 of 65 (1.5%)	61 of 65 (93.8%)	Not reported
Neulasta® (Pegfilgrastim)	4 of 65 (6.2%)	59 of 65 (90.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38194162Glaspy 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing F-627 and Neulasta® (pegfilgrastim) in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Moderate Neurtopenia Post First Chemotherapy Administration (time frame: The first of 4, 21 Day Chemotherapy Cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01648322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.