Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia

NCT03559387 | Terminated Phase 2

• 1 other identifier: PGFN-001
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 8

Brief Summary

Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia

Conditions

Chemotherapy-induced Neutropenia

Outcome Measures

Primary Outcomes (1)

• Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the first cycle of chemotherapy (FE100C).

  21 days

Secondary Outcomes (25)

• Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 10^9/L) in the fourth cycle of chemotherapy (docetaxel).

  21 days

• Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the first chemotherapy cycle (21-day cycle FE100C)

  21 days

• Duration of severe neutropenia (ANC < 0.5 x 10^9/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)

  21 days

• Incidence of severe neutropenia (ANC < 0.5 x 10^9/L) during all chemotherapy cycles

  ~ 128 ± 2 days

• Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C and ANC < 0.5 x 10^9/L, during all chemotherapy cycles

  ~ 128 ± 2 days

Study Arms (2)

ANF-RHO™

EXPERIMENTAL

Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg as a subcutaneous injection.

Drug: ANF-RHO™

Neulasta®

ACTIVE COMPARATOR

Neulasta® will be administered to the subjects at a dose of 6.0 mg in 0.6 ml as a subcutaneous injection.

Drug: Neulasta®

Interventions

ANF-RHO™ DRUG

Subjects randomized to the ANF-RHO™ treatment arm will receive the investigational product on Day 1(day of chemotherapy treatment) of each Chemotherapy cycle. ANF-RHO™ will be administered to the subjects as a subcutaneous injection. Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg. ANF-RHO™ is provided as a single-use glass vial containing 1.0 ml of solution at a concentration of 5 mg/ml

Also known as: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)

ANF-RHO™

Neulasta® DRUG

Subjects randomized to the Neulasta® treatment arm will receive the comparator drug on Day 2(day after chemotherapy treatment) of each Chemotherapy cycle. Neulasta® will be administered to the subjects at a standard dose of 6.0 mg in 0.6 ml as a subcutaneous injection. Neulasta® is also provided as a single-use pre-filled syringe.

Also known as: Pegylated Granulocyte Colony-Stimulating Factor (PEG-GCSF)

Neulasta®

Eligibility Criteria

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

You may qualify if:

• Adult female patients, 18 years of age or older
• Signed and dated written consent/assent by the patient or legally authorized representative
• Histologically confirmed non-metastatic breast cancer
• ECOG performance status ≤ 2
• Myelosuppressive chemotherapy naive
• Scheduled to receive and anticipated to complete the following chemotherapy regimen
• FEC (fluorouracil/epirubicin (100) / cyclophosphamide) (3 cycles);
• Docetaxel (3 cycles) chemotherapy
• White blood cells (WBC) ≥ 3 × 10\^9/L; Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L; platelet count ≥ 100 × 10\^9/L; and hemoglobin ≥ 10 g/dL (6.2 mmol/L)
• Adequate cardiac function (e.g. LVEF \> 50% as determined by standard care) and adequate hepatic function (e.g. liver transaminases \< 2.5 x ULN)
• Women of childbearing potential with a negative serum pregnancy test and using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives and intrauterine devices (IUDs)). Periodic abstinence is not an acceptable contraceptive method during the study period.

You may not qualify if:

• Known hypersensitivity to E.coli derived products or polyethylene glycol
• No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥ 5 years ago with curative intent
• Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease
• Clinical diagnosis or history of chronic infection such as hepatitis B virus (HBV), hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or history of tuberculosis
• Previous exposure to filgrastim, perfilgrastim or lipegfilgrastim within 30 days before randomization
• Treatment with systemically active antibiotics within 72 hours before chemotherapy
• Chronic use of oral corticosteroids
• Participation in a pharmacological clinical trial within 30 days before randomization
• Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening
• Documented alcohol abuse within 30 days prior to screening
• Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol
• Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test
• Other serious medical condition that would prevent individual from receiving protocol treatment

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (8)

Hôpital Saint Louis - Center des Maladies du Sein

Paris, 75475, France

Location

Institut de cancérologie Jean Godinot

Reims, 51100, France

Location

Strasbourg Oncologie Libérale

Strasbourg, 67000, France

Location

CHU de Tours

Tours, 37044, France

Location

Erasmus Medical Center

Rotterdam, 3008, Netherlands

Location

Ikazia Ziekenhuis

Rotterdam, 3038, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3079, Netherlands

Location

Franciscus Gasthuis & Vlietland

Schiedam, 3118, Netherlands

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor; pegfilgrastim

Study Design

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

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 18, 2018
• Study Start: August 3, 2017
• Primary Completion: April 18, 2018
• Study Completion: May 22, 2018
• Last Updated: February 12, 2019

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); NL (4)