Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients

NCT00711958 | Completed Phase 3 Results

• 1 other identifier: 2003-31-INJ-11
• Study Type: interventional
• Target: 114
• Locations: 2 countries
• Sites: 19

Brief Summary

This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.

Conditions

Anemia

Keywords

Chemotherapy associated anemia in cancer patients

Outcome Measures

Primary Outcomes (1)

• Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia

  Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.

  5-12 weeks

Study Arms (2)

HX575 epoetin alfa Hexal AG

EXPERIMENTAL

HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.

Drug: HX575, solution for injection (s.c.)

ERYPO® Janssen-Cilag

ACTIVE COMPARATOR

ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.

Drug: ERYPO®, Janssen-Cilag, solution for injection (s.c.)

Interventions

HX575, solution for injection (s.c.) DRUG

1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin

Also known as: Binocrit, Erythropoeitin alfa Hexal, Abseamed

HX575 epoetin alfa Hexal AG

ERYPO®, Janssen-Cilag, solution for injection (s.c.) DRUG

1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

Also known as: Eprex

ERYPO® Janssen-Cilag

Eligibility Criteria

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

You may qualify if:

• Patients with a confirmed diagnosis of solid tumors
• Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4 weeks (for at least 12 weeks) during the study
• Patients with chemotherapy associated anemia (hemoglobin \< 10.0 g/dl at screening)
• Life expectancy of at least 6 months Age: \> 18
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2
• Serum ferritin greater or equal to 100 µg/l and/or saturated transferrin levels greater or equal to 20 %
• Adequate renal function (serum creatinine below or equal to 2.0 mg/dl)
• Adequate hepatic function (bilirubin \< 1.5 times upper limit of normal range
• Patients with ability to follow study instructions, likely to complete all required visits and able to perform the quality of life assessment
• Written informed consent of the patient

You may not qualify if:

• Patients who receive curative intended chemotherapy
• Known primary or metastatic malignancy of the central nervous system
• Known primary or metastatic malignancy of bone marrow
• Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, acute leukemia)
• Thrombotic events during the last 6 months
• Suspicion or known PRCA (pure red cell aplasia)
• Transfusion of white blood cells or packed red blood cells (more than 2 packs) within 4 weeks and any transfusion of white blood cells or packed red blood cells within 2 weeks prior to randomization (visit 0)
• Anemia due to overt bleeding or hemolysis within 2 weeks before screening
• Erythropoietin or Darbepoietin therapy within 8 weeks before screening, including any investigational form of erythropoietin (e.g. gene-activated erythropoietin, novel erythropoiesis stimulating protein)
• Radiation therapy during the study, radiation therapy induced anemia
• Therapy with cyclosporine
• Chemotherapy which causes predictable treatment with peripheral-blood progenitor therapy, e.g. G-CSF
• Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone \>1500 pg/mL)
• Major surgery within 14 days prior to randomization
• Treatment with antiepileptics within the last 5 years

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (19)

Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter

Augsburg, 86150, Germany

Location

Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie

Bad Soden, 65812, Germany

Location

Poliklinik am Paritätischen Krankenhaus

Berlin, 10365, Germany

Location

Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie

Berlin, 10367, Germany

Location

Oskar-Helene-Heim

Berlin, 14195, Germany

Location

Praxis Drs. Marschner, Zeiss, Kirste

Freiburg im Breisgau, 79106, Germany

Location

DRK-Krankenhaus

Luckenwalde, 14943, Germany

Location

Praxis für Onkologie

Munich, 80637, Germany

Location

Praxis Drs. Kowolik/Prechtl

Munich, 81925, Germany

Location

Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13

Nuremberg, 90419, Germany

Location

Gemeinschaftspraxis

Stuttgart, 70173, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Universitätsklinikum Tübingen Medizinische Klinik 1

Tübingen, 72076, Germany

Location

Gemeinschaftspraxis für internistische Onkologie

Velbert, 42551, Germany

Location

Praxis für internistische Onkologie

Weiden, 92637, Germany

Location

Oncologic Institute

Cluj-Napoca, 400015, Romania

Location

Country hospital Oradea

Oradea, 410032, Romania

Location

County Hospital Satu-Mare

Satu Mare, 440192, Romania

Location

Oncomed SRL Timisoara

Timișoara, 300239, Romania

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa; Solutions; Injections

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; 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; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Biopharmaceutical Clinical Development, Strategic Planning
• Organization: Sandoz

biopharma.clinicaltrials@sandoz.com

0049 80244760

Study Officials

• Andrea Vetter, Dr.

  Hexal AG

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: November 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: December 1, 2005
• Last Updated: September 5, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (4); DE (15)