Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

NCT01519700 | Completed Phase 3 Results DMC

• 2 other identifiers: EP06-3022010-024481-22
• Study Type: interventional
• Target: 218
• Locations: 6 countries
• Sites: 26

Brief Summary

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Conditions

Chemotherapy Associated Neutropenia; Breast Cancer

Keywords

Filgrastim; G-CSF, neutropenia; supportive care; breast cancer

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy

  Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5\*10\^9 cells/L)

  21 days (Cycle 1 of chemotherapy treatment)

Secondary Outcomes (6)

• Incidence of Febrile Neutropenia

  21 weeks/ 6 cycles

• Number of Days of Fever

  21 weeks/ 6 cycles

• Depth of Absolute Neutrophil Count Nadir

  Cycle 1/ 21 days

• Time to Absolute Neutrophil Count Recovery

  Cycle 1/ 21 days

• Frequency of Infections

  21 Weeks/ 6 cycles

Study Arms (2)

EP2006

EXPERIMENTAL

Eligible patients will be teated with EP2006

Drug: EP2006

Filgrastim

ACTIVE COMPARATOR

Eligible patients will be teated with Filgrastim

Drug: Filgrastim

Interventions

EP2006 DRUG

Eligible patients will be teated with EP2006

Also known as: Filgrastim

EP2006

Filgrastim DRUG

Eligible patients will be teated with Filgrastim

Filgrastim

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
• Women ≥ 18 years of age
• Estimated life expectancy of more than six months

You may not qualify if:

• Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
• Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:

Sponsors & Collaborators

• Sandoz: lead

Study Sites (26)

Insitut Onkologie a Rehabilitaca na Plesi

Ves Pod Plesi 110, 26204, Czechia

Location

Semmelweis Egyetem, III. Belgyogyaszati Klinika

Budapest, 1125, Hungary

Location

Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia

Budapest, 1145, Hungary

Location

DE OEC, Onkologiai Tanszek

Debrecen, 4032, Hungary

Location

Josa Andras Oktato Korhaz Nonprofit Kft

Nyíregyháza, 4400, Hungary

Location

Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly

Székesfehérvár, 8000, Hungary

Location

Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly

Szombathely, 9700, Hungary

Location

Daugavpils Regional Hospital

Daugavpils, 5400, Latvia

Location

Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS

Moscow, Krasnogorsk District, 143423, Russia

Location

State Healthcare Institution (SHI) "Leningrad Regional Oncological Dispensary" at the Surgery Department 2

Kuzmolovsky, Leningradskaya Oblast', 188663, Russia

Location

State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary

Chelyabinsk, 454087, Russia

Location

State Healthcare Institution (SHI) "Clinical Oncological Dispensary №1" of Healthcare Department of Krasnodar Territory

Krasnodar, 350040, Russia

Location

Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS", Surgery Department of the Female Reproductive System Tumors

Moscow, 115478, Russia

Location

Affiliate No1 of State Healthcare Institution (SHI) "Nizhny Novgorod Regional Oncological Dispensary"

Nizhny Novgorod, 603081, Russia

Location

Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS

Obninsk, 249036, Russia

Location

State Healthcare Institution SHI Pyatigorsk Oncological Dispensary

Pyatigorsk, 357502, Russia

Location

Non-State Healthcare Institution NSHI

Saint Petersburg, 195271, Russia

Location

Saint-Petersburg State Healthcare Institution (SPb SHI) "City Clinical Oncological Dispensary"

Saint Petersburg, 197022, Russia

Location

State Healthcare Institution (SHI)"Voronezh Regional Clinical Oncological Dispensary"

Voronezh, 394000, Russia

Location

Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie

Nitra, 95001, Slovakia

Location

Communal Institution "Krivorizhskiy oncology dispensary" of Dnipropetrovsk regional Council, Chemotherapy Department

Kryvyi Rih, Dnipropetrovsk Oblast, 50048, Ukraine

Location

Communal Institution "Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4" of Dnipropetrovsk Regional Council

Dnipropetrovsk, 49102, Ukraine

Location

Medical center of Limited Liability Company "Inter"

Luhansk, 91000, Ukraine

Location

Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department

Lviv, 79031, Ukraine

Location

Communal Institution "Odesa regional clinical hospital", Mammology Center

Odesa, 65025, Ukraine

Location

Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department

Vinnitsya, 21029, Ukraine

Location

Related Publications (1)

• Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-1953. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.

  PMID: 26122726 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Roumen Nakov, Global Programme Medical Director
• Organization: Sandoz

roumen.nakov@sandoz.com

+49 8024 4764704

Study Officials

• Sandoz

  Sandoz

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 27, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 6, 2015
• Results First Posted: April 7, 2015

Record last verified: 2015-04

Locations

HU (6); LA (1); CZ (1); RU (11); SL (1); UA (6)