SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

NCT ID: NCT02953340

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2019-05-06

Brief Summary

The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).

Detailed Description

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN).

Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).

After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.

Conditions

Neutropenia; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

(Arm 1): SPI-2012 and TC

At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

Group Type: EXPERIMENTAL

SPI-2012

Intervention Type: DRUG

Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

Docetaxel

Intervention Type: DRUG

75mg/m\^2 IV infusion administered on Day 1 of each cycle

Cyclophosphamide

Intervention Type: DRUG

600mg/m\^2 IV infusion administered on Day 1 of each cycle

(Arm 2): Pegfilgrastim and TC

At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

Subcutaneous injection administered on Day 2 of each cycle.

Docetaxel

Intervention Type: DRUG

75mg/m\^2 IV infusion administered on Day 1 of each cycle

Cyclophosphamide

Intervention Type: DRUG

600mg/m\^2 IV infusion administered on Day 1 of each cycle

Interventions

SPI-2012

Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle

Intervention Type: DRUG

Pegfilgrastim

Subcutaneous injection administered on Day 2 of each cycle.

Intervention Type: DRUG

Docetaxel

75mg/m\^2 IV infusion administered on Day 1 of each cycle

Intervention Type: DRUG

Cyclophosphamide

600mg/m\^2 IV infusion administered on Day 1 of each cycle

Intervention Type: DRUG

Other Intervention Names

HM10460A; Rolontis®; Eflapegrastim; Neulasta®; Taxotere; Cytoxan

Eligibility Criteria

Inclusion Criteria

• New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
• Candidate for adjuvant or neo-adjuvant TC chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2
• Absolute neutrophil count (ANC) >=1.5×10^9/L
• Platelet count >=100×10^9/L
• Hemoglobin >9 g/dL
• Calculated creatinine clearance > 50 mL/min
• Total bilirubin <=1.5 mg/dL
• Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) <=2.5×ULN (upper limit of normal)
• Alkaline phosphatase <=2.0×ULN

Exclusion Criteria

• Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
• Locally recurrent/metastatic breast cancer
• Known sensitivity to E. coli-derived products
• Concurrent adjuvant cancer therapy
• Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
• Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
• Prior bone marrow or stem cell transplant
• Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
• Major surgery within 30 days prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ACRC/ Arizona Clinical Research Center Inc.

Tucson, Arizona, United States

Yuma Regional Cancer Center

Yuma, Arizona, United States

Genesis Cancer Center

Hot Springs, Arkansas, United States

NEA Baptist Clinic | Fowler Family Center for Cancer Care

Jonesboro, Arkansas, United States

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Compassionate Care Research Group, Inc.

Fountain Valley, California, United States

California Cancer Associates for Research and Excellence Inc.

Fresno, California, United States

Pacific Shores Medical Group

Long Beach, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Emad Ibrahim, MD, INC.

Redlands, California, United States

Innovative Clinical Research Institute/ The Oncology Institute of Hope and Innovation

Whittier, California, United States

Denver Health & Hospital Authority

Denver, Colorado, United States

Pasco Pinellas Cancer Center

Holiday, Florida, United States

Lakes Research, LLC

Miami Lakes, Florida, United States

Mid-Florida Hematology and Oncology Centers

Orange City, Florida, United States

Millennium Oncology

Pembroke Pines, Florida, United States

BRCR Medical Center Inc

Plantation, Florida, United States

Pinellas Hematology and Oncology

St. Petersburg, Florida, United States

Bond & Steele Clinic, PA.

Winter Haven, Florida, United States

John B. Amos Cancer Center

Columbus, Georgia, United States

Cancer Center of Middle Georgia

Dublin, Georgia, United States

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Oncology Specialists, SC

Park Ridge, Illinois, United States

FPN Oncology and Hematology Specialists

Indianapolis, Indiana, United States

Commonwealth Hematology-Oncology, PSC

Danville, Kentucky, United States

Pontchartrain Cancer Center

Covington, Louisiana, United States

Quest Research Institute

Royal Oak, Michigan, United States

Coborn Cancer Center

Saint Cloud, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, United States

Freeman Health Systems

Joplin, Missouri, United States

St. Vincent Frontier Cancer Center

Billings, Montana, United States

CHI Health St Francis, St Francis Cancer Treatment Center

Grand Island, Nebraska, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

Gaston Hematology & Oncology Associates, PC

Gastonia, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

St. Elizabeth Youngstown Hospital JACBCC/Oncology/ Mercy Health Youngstown LLC

Youngstown, Ohio, United States

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

The West Clinic, PC, d/b/a West Cancer Center

Germantown, Tennessee, United States

CHI St Joseph Health Cancer Center

Bryan, Texas, United States

Envision Cancer Center, LLC

Laredo, Texas, United States

Texas Oncology, PA- McAllen South 2nd Street

McAllen, Texas, United States

HOPE Cancer Center of East Texas

Tyler, Texas, United States

Delta Hematology/Oncology Associates

Portsmouth, Virginia, United States

Providence Regional Center Partnership

Everett, Washington, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

CISSS de la Montérégie-Centre

Longueuil, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

Budapest, , Hungary

Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly

Budapest, , Hungary

Orszagos Onkologiai Intezet, ""B"" Belgyogyaszati Onkologiai Osztaly

Budapest, , Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Okato Korhaz, Klinikai Onkologiai es Sugarterapias Centrum

Miskolc, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak, Egyetemi Oktato Korhaz, Onkoradiologiai Osztaly

Nyíregyháza, , Hungary

Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly

Szekszárd, , Hungary

KEM Hospital Research Centre

Pune, Maharashtra, India

Christian Medical College

Vellore, Tamil Nadu, India

BIALOSTOCKIE CENTRUM ONKOLOGII im. Marii Sklodowskiej-Curie Oddzial Onkologii Klinicznej im. Ewy Pileckiej z Pododdzialem Chemioterapii dziennej

Bialystok, , Poland

Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej

Grudziądz, , Poland

Instytut Centrum Zdrowia Matki Polki Klinika Chirurgii Onkologicznej i Chorob Piersi z Pododdzialem Onkologii Klinicznej

Lodz, , Poland

Pracownia Leku Cytotoksycznego Szpitala Klinicznego Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Szpital Rejonowy im. Dr. Jozefa Rostka w Raciborzu Dzienny Oddzial Chemioterapii

Racibórz, , Poland

MrukMed. Lekarz Beata Madej Mruk i Partner. Spolka Partnerska Oddzial nr 1 w Rzeszowie

Rzeszów, , Poland

Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, , Poland

Samsung Medical Center

Irwon-ro, Gangnam-gu Seoul, South Korea

Wonju Severance Christian Hospital

Ilsan-ro, Gangwon-do, South Korea

National Cancer Center

IIsan-ro, Gyeonggi-do, South Korea

Cha Bundang Medical Center

Yatap-ro, Gyeonggi-do, South Korea

Seoul National University Hospital

Daehwa-ro, Jongno-gu Seoul, South Korea

Inha University Hospital

Inhang-ro, Jung-guIncheon, South Korea

Korea University Anam Hospital

Inchon-ro, Seongbuk-guSeoul, South Korea

Severance Hospital

Yonsei-ro, Seoul, South Korea

Countries

United States; Canada; Hungary; India; Poland; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-003469-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPI-GCF-302

Identifier Type: -

Identifier Source: org_study_id