Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

NCT01724866 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: SPI-GCF-12-2012013-003094-10
• Study Type: interventional
• Target: 148
• Locations: 6 countries
• Sites: 27

Brief Summary

The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.

Conditions

Neutropenia

Outcome Measures

Primary Outcomes (1)

• Duration of Severe Neutropenia (DSN) in Cycle 1

  DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 1.

  Cycle 1 (each cycle was 21 days)

Secondary Outcomes (27)

• Duration of DSN in Cycle 2

  Cycle 2 (each cycle was 21 days)

• Duration of DSN in Cycle 3

  Cycle 3 (each cycle was 21 days)

• Duration of DSN in Cycle 4

  Cycle 4 (each cycle was 21 days)

• Time to ANC Recovery in Cycle 1

  Cycle 1 (each cycle was 21 days)

• Time to ANC Recovery in Cycle 2

  Cycle 2 (each cycle was 21 days)

Study Arms (4)

Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

Participants received SPI-2012 45 microgram/kilogram (µg/kg), subcutaneously (SC) once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 milligram/ square metre (mg/m\^2) intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

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

Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

Participants received SPI-2012 135 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

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

Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

Participants received SPI-2012 270 µg/kg, SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

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

Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

EXPERIMENTAL

Participants received Pegfilgrastim 6 milligram (mg), SC once per cycle on Day 2 of each cycle up to cycle 4 (each cycle was 21 days), approximately 24 hours after the administration of TC chemotherapy. TC chemotherapy was administered on Day 1 of each cycle as follows: Docetaxel 75 mg/m\^2 intravenous (IV) infusion over 60 minutes and Cyclophosphamide 600 mg/m\^2 IV infusion over 30-60 minutes.

Drug: Pegfilgrastim; Drug: Docetaxel; Drug: Cyclophosphamide

Interventions

SPI-2012 DRUG

SPI-2012 SC injection.

Also known as: Rolontis®, HM10460A, Eflapegrastim

Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC)

Pegfilgrastim DRUG

Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

Also known as: Neulasta®

Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Docetaxel DRUG

Docetaxel given based on standard dose for chemotherapy.

Also known as: Taxotere

Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Cyclophosphamide DRUG

Cyclophosphamide given based on standard dose for chemotherapy.

Also known as: Cytoxan

Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 2: SPI-2012 135 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 3: SPI-2012 270 µg/kg and Docetaxel + Cyclophosphamide (TC); Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed breast cancer and candidate for adjuvant or neoadjuvant chemotherapy
• Candidate for docetaxel and cyclophosphamide chemotherapy
• Female or male at least 18 years of age
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Absolute neutrophil count (ANC) ≥ 1.5×109/L
• Platelet count ≥ 100 x 10\^9/L
• Creatinine ≤ 1.5 x upper limit of normal (ULN)
• Total bilirubin ≤1.5 mg/dL(≤ 25.65 μmol/L).
• Aspartate aminotransferase per serum glutamic-oxaloacetic transaminase (AST/SGOT) and/or alanine aminotransferase per serum glutamic-pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
• Hemoglobin \> 9 g/dL
• Alkaline phosphatase ≤ 1.5 x ULN

You may not qualify if:

• Known sensitivity to E. coli-derived products or known sensitivity to any of the products to be administered
• Known Human Immunodeficiency Virus (HIV) infection
• Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) diagnosis with detectable viral load or immunological evidence of chronic active disease
• Active infection or any serious underlying medical condition that would impair ability to receive protocol treatment
• Prior bone marrow or stem cell transplant
• Prolonged exposure to glucocorticosteroids and immunosuppressive agents

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (27)

Arizona Center for Cancer Care

Glendale, Arizona, 85306, United States

Location

Desert Springs Cancer Care

Scottsdale, Arizona, 85255, United States

Location

California Cancer Associates for Research and Excellence

Fresno, California, 93720, United States

Location

Beaver Medical Group

Highland, California, 92346, United States

Location

California Cancer Associates for Research and Excellence

Los Angeles, California, 92025, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

Kentucky Cancer Clinic

Hazard, Kentucky, 41701, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12206, United States

Location

North Shore Hematology/Oncology Associates

Setauket, New York, 11733, United States

Location

Good Samaritan Hospital, Corvallis

Corvallis, Oregon, 97330, United States

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Royal Hobart

Brisbane, 7000, Australia

Location

Ashford Cancer Center Research

Kurralta Park, 5037, Australia

Location

Breast Cancer Research Center, WA

Perth, 6000, Australia

Location

Ballarat Oncology & Haematology

Wendouree, 3355, Australia

Location

LTD " Cancer Center of Adjara Autonomic Republic"

Batumi, 6000, Georgia

Location

Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic

Tbilisi, 0186, Georgia

Location

State Health Center

Budapest, 1062, Hungary

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Uzsoki Hospital

Budapest, 1146, Hungary

Location

University Debrecen, Oncology Clinic

Debrecen, 4032, Hungary

Location

Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház

Nyíregyháza, Hungary

Location

Ziv Medical Center

Safed, 13100, Israel

Location

Regionalny Szpital Specjalistyczny

Grudziądz, 86-300, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Dzienny Oddział Chemioterapii

Racibórz, 47-400, Poland

Location

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-106, Poland

Location

Related Publications (1)

• Vacirca JL, Chan A, Mezei K, Adoo CS, Papai Z, McGregor K, Okera M, Horvath Z, Landherr L, Hanslik J, Hager SJ, Ibrahim EN, Rostom M, Bhat G, Choi MR, Reddy G, Tedesco KL, Agajanian R, Lang I, Schwartzberg LS. An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer. Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.

  PMID: 29573207 DERIVED

MeSH Terms

Conditions

Neutropenia

Interventions

eflapegrastim; pegfilgrastim; Docetaxel; Cyclophosphamide

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

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

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: November 12, 2012
• Study Start: March 25, 2013
• Primary Completion: August 12, 2014
• Study Completion: August 12, 2014
• Last Updated: April 15, 2022
• Results First Posted: April 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5); GE (2); PL (4); IL (1); AU (5); US (10)