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

NCT02953340 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: SPI-GCF-3022016-003469-24
• Study Type: interventional
• Target: 237
• Locations: 6 countries
• Sites: 74

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).

Conditions

Neutropenia; Breast Cancer

Keywords

Neutropenia; Breast Cancer; Long-acting Granulocyte Colony Stimulating Factor; Early Stage Breast Cancer; Docetaxel + Cyclophosphamide (TC) chemotherapy

Outcome Measures

Primary Outcomes (1)

• Duration of Severe Neutropenia (DSN) in Cycle 1

  DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.

  Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

Secondary Outcomes (9)

• Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1

  Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

• Depth of ANC Nadir in Cycle 1

  Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

• Number of Participants With Febrile Neutropenia (FN) in Cycle 1

  Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

• Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4

  Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)

• Number of Participants With Neutropenic Complications in Cycle 1

  Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

Study Arms (2)

(Arm 1): SPI-2012 and TC

EXPERIMENTAL

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.

Drug: SPI-2012; Drug: Docetaxel; Drug: Cyclophosphamide

(Arm 2): Pegfilgrastim and TC

EXPERIMENTAL

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.

Drug: Pegfilgrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

SPI-2012 DRUG

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

Also known as: HM10460A, Rolontis®, Eflapegrastim

(Arm 1): SPI-2012 and TC

Pegfilgrastim DRUG

Subcutaneous injection administered on Day 2 of each cycle.

Also known as: Neulasta®

(Arm 2): Pegfilgrastim and TC

Docetaxel DRUG

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

Also known as: Taxotere

(Arm 1): SPI-2012 and TC; (Arm 2): Pegfilgrastim and TC

Cyclophosphamide DRUG

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

Also known as: Cytoxan

(Arm 1): SPI-2012 and TC; (Arm 2): Pegfilgrastim and TC

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (74)

ACRC/ Arizona Clinical Research Center Inc.

Tucson, Arizona, 85715, United States

Location

Yuma Regional Cancer Center

Yuma, Arizona, 85364, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

NEA Baptist Clinic | Fowler Family Center for Cancer Care

Jonesboro, Arkansas, 72401, United States

Location

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Compassionate Care Research Group, Inc.

Fountain Valley, California, 92708, United States

Location

California Cancer Associates for Research and Excellence Inc.

Fresno, California, 93720, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

Emad Ibrahim, MD, INC.

Redlands, California, 92373, United States

Location

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

Whittier, California, 90603, United States

Location

Denver Health & Hospital Authority

Denver, Colorado, 80204, United States

Location

Pasco Pinellas Cancer Center

Holiday, Florida, 34691, United States

Location

Lakes Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Mid-Florida Hematology and Oncology Centers

Orange City, Florida, 32763, United States

Location

Millennium Oncology

Pembroke Pines, Florida, 33024, United States

Location

BRCR Medical Center Inc

Plantation, Florida, 33324, United States

Location

Pinellas Hematology and Oncology

St. Petersburg, Florida, 33709, United States

Location

Bond & Steele Clinic, PA.

Winter Haven, Florida, 33880, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Cancer Center of Middle Georgia

Dublin, Georgia, 31021, United States

Location

Dwight D. Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

Location

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

FPN Oncology and Hematology Specialists

Indianapolis, Indiana, 46237, United States

Location

Commonwealth Hematology-Oncology, PSC

Danville, Kentucky, 40422, United States

Location

Pontchartrain Cancer Center

Covington, Louisiana, 70433, United States

Location

Quest Research Institute

Royal Oak, Michigan, 48073, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States

Location

Freeman Health Systems

Joplin, Missouri, 64804, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

CHI Health St Francis, St Francis Cancer Treatment Center

Grand Island, Nebraska, 68803, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

Gaston Hematology & Oncology Associates, PC

Gastonia, North Carolina, 28054, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

The Christ Hospital Cancer Center

Cincinnati, Ohio, 45219, United States

Location

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

Youngstown, Ohio, 44501, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

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

Germantown, Tennessee, 38138, United States

Location

CHI St Joseph Health Cancer Center

Bryan, Texas, 77802, United States

Location

Envision Cancer Center, LLC

Laredo, Texas, 78041, United States

Location

Texas Oncology, PA- McAllen South 2nd Street

McAllen, Texas, 78503, United States

Location

HOPE Cancer Center of East Texas

Tyler, Texas, 75701, United States

Location

Delta Hematology/Oncology Associates

Portsmouth, Virginia, 23704, United States

Location

Providence Regional Center Partnership

Everett, Washington, 98201, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

CISSS de la Montérégie-Centre

Longueuil, Quebec, J4V 2H1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

Budapest, 1062, Hungary

Location

Szent Imre Egyetemi Oktatokorhaz, Klinikai Onkologiai Osztaly

Budapest, 1115, Hungary

Location

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

Budapest, 1122, Hungary

Location

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

Miskolc, 3526, Hungary

Location

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

Nyíregyháza, 4400, Hungary

Location

Tolna Megyei Balassa Janos Korhaz, Klinikai Onkologiai Osztaly

Szekszárd, 7100, Hungary

Location

KEM Hospital Research Centre

Pune, Maharashtra, 411011, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

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

Bialystok, 15-027, Poland

Location

Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego Oddział Onkologii Klinicznej

Grudziądz, 86-300, Poland

Location

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

Lodz, 93-338, Poland

Location

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

Poznan, 60-569, Poland

Location

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

Racibórz, 47-400, Poland

Location

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

Rzeszów, 35-021, Poland

Location

Zachodniopomorskie Centrum Onkologii Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, 71-730, Poland

Location

Samsung Medical Center

Irwon-ro, Gangnam-gu Seoul, 06351, South Korea

Location

Wonju Severance Christian Hospital

Ilsan-ro, Gangwon-do, 26426, South Korea

Location

National Cancer Center

IIsan-ro, Gyeonggi-do, 10408, South Korea

Location

Cha Bundang Medical Center

Yatap-ro, Gyeonggi-do, 13496, South Korea

Location

Seoul National University Hospital

Daehwa-ro, Jongno-gu Seoul, 03080, South Korea

Location

Inha University Hospital

Inhang-ro, Jung-guIncheon, 22332, South Korea

Location

Korea University Anam Hospital

Inchon-ro, Seongbuk-guSeoul, 02841, South Korea

Location

Severance Hospital

Yonsei-ro, Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Neutropenia; Breast Neoplasms

Interventions

eflapegrastim; pegfilgrastim; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Shanta Chawla
• Organization: Spectrum Pharmaceuticals Inc. Research and Development Office 157 Technology Drive Irvine, CA 92618

shanta.chawla@sppirx.com

(949) 788-6700

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 2, 2016
• Study Start: May 10, 2017
• Primary Completion: June 8, 2018
• Study Completion: May 6, 2019
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (49); HU (6); PL (7); KR (8); IN (2)