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

NCT ID: NCT01724866

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-25
• Study Completion Date: 2014-08-12

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.

Detailed Description

This is an open label, multicenter, dose ranging study, sequentially enrolled by study dose, with a non-inferiority design to compare the effectiveness of SPI-2012 relative to a fixed dose of pegfilgrastim as a concurrent active control to each dose of SPI-2012 in participants with breast cancer. This study included four arms comprising three dose levels of SPI-2012 (Arm 1: 45 µg/kg, Arm 2: 135 µg/kg, Arm 3: 270 µg/kg) versus pegfilgrastim (Arm 4: 6 mg). The start of study is defined as the initiation of treatment with SPI-2012 or pegfilgrastim. The duration of treatment consists of a maximum of 4 cycles (21 days per cycle) beginning on Day 1 with chemotherapy administration and continue through Day 21, plus a 30-day follow-up period, unless any of the discontinuation criteria applies.

The target population are participants with breast cancer who are candidates for neoadjuvant or adjuvant treatment with Docetaxel + Cyclophosphamide (TC) chemotherapy. All participants who receive at least 1 dose of either SPI-2012 or pegfilgrastim were followed for safety through 30 days after their last dose of study treatment or until all treatment-related adverse events (AEs) have resolved or returned to baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow-up.

Conditions

Neutropenia

Study Design

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

Study Groups

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

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.

Group Type: EXPERIMENTAL

SPI-2012

Intervention Type: DRUG

SPI-2012 SC injection.

Docetaxel

Intervention Type: DRUG

Docetaxel given based on standard dose for chemotherapy.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide given based on standard dose for chemotherapy.

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

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.

Group Type: EXPERIMENTAL

SPI-2012

Intervention Type: DRUG

SPI-2012 SC injection.

Docetaxel

Intervention Type: DRUG

Docetaxel given based on standard dose for chemotherapy.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide given based on standard dose for chemotherapy.

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

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.

Group Type: EXPERIMENTAL

SPI-2012

Intervention Type: DRUG

SPI-2012 SC injection.

Docetaxel

Intervention Type: DRUG

Docetaxel given based on standard dose for chemotherapy.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide given based on standard dose for chemotherapy.

Arm 4: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)

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.

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

Docetaxel

Intervention Type: DRUG

Docetaxel given based on standard dose for chemotherapy.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide given based on standard dose for chemotherapy.

Interventions

SPI-2012

SPI-2012 SC injection.

Intervention Type: DRUG

Pegfilgrastim

Pegfilgrastim SC injection, per manufacturer's Prescribing Information.

Intervention Type: DRUG

Docetaxel

Docetaxel given based on standard dose for chemotherapy.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide given based on standard dose for chemotherapy.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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

Arizona Center for Cancer Care

Glendale, Arizona, United States

Desert Springs Cancer Care

Scottsdale, Arizona, United States

California Cancer Associates for Research and Excellence

Fresno, California, United States

Beaver Medical Group

Highland, California, United States

California Cancer Associates for Research and Excellence

Los Angeles, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

Kentucky Cancer Clinic

Hazard, Kentucky, United States

New York Oncology Hematology, PC

Albany, New York, United States

North Shore Hematology/Oncology Associates

Setauket, New York, United States

Good Samaritan Hospital, Corvallis

Corvallis, Oregon, United States

Frankston Hospital

Frankston, Victoria, Australia

Royal Hobart

Brisbane, , Australia

Ashford Cancer Center Research

Kurralta Park, , Australia

Breast Cancer Research Center, WA

Perth, , Australia

Ballarat Oncology & Haematology

Wendouree, , Australia

LTD " Cancer Center of Adjara Autonomic Republic"

Batumi, , Georgia

Ltd ' Medulla - Chemotherapy and Immunotherapy Clinic

Tbilisi, , Georgia

State Health Center

Budapest, , Hungary

National Institute of Oncology

Budapest, , Hungary

Uzsoki Hospital

Budapest, , Hungary

University Debrecen, Oncology Clinic

Debrecen, , Hungary

Szabolcs - Szatmár - Bereg megyei Kórházak és Egyetemi Oktatókórház

Nyíregyháza, , Hungary

Ziv Medical Center

Safed, , Israel

Regionalny Szpital Specjalistyczny

Grudziądz, , Poland

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Dzienny Oddział Chemioterapii

Racibórz, , Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, , Poland

Countries

United States; Australia; Georgia; Hungary; Israel; Poland

References

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.

Reference Type: DERIVED

PMID: 29573207 (View on PubMed)

Other Identifiers

2013-003094-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPI-GCF-12-201

Identifier Type: -

Identifier Source: org_study_id