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

This study has been completed.
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT00711958
First received: July 3, 2008
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: HX575, solution for injection (s.c.)
Drug: ERYPO®, Janssen-Cilag, solution for injection (s.c.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Efficacy of HX575 in the treatment of chemotherapy associated anemia [ Time Frame: 5-12 weeks ] [ Designated as safety issue: Yes ]
    Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.


Secondary Outcome Measures:
  • Safety of HX575 in the treatment of chemotherapy associated anemia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Incidence and severity of all and of all drug related adverse events


Enrollment: 105
Study Start Date: November 2004
Study Completion Date: December 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HX575 epoetin alfa Hexal AG
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.)
1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
Other Name: Binocrit, Erythropoeitin alfa Hexal, Abseamed
Active Comparator: ERYPO® Janssen-Cilag
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.)
1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Other Name: Eprex

Detailed Description:
Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased <1.0 g/dL or the reticulocyte count increased <40,000 /μl after 4 weeks or if Hb increased <2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Previously diagnosed HIV or acute hepatitis infection
  • Uncontrolled hypertension, defined as a diastolic blood pressure measurement >110mm Hg during the screening period
  • History of congestive heart failure (NYHA class III, IV)
  • Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
  • Evidence of acute infectious disease or serious active inflammatory disease within four weeks before screening (Visit -1) or during the screening/baseline period
  • Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
  • Pregnancy, breastfeeding women or women not using adequate birth control measures
  • Patients who participate simultaneously in another clinical study or who have participated in a study in the month preceding the start of this study or previously randomized to this study (except studies with approved medications in an approved indication, with an approved dosing regimen including approved treatment combinations)
  • Suspicion of any non-compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711958

Locations
Germany
Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter
Augsburg, Germany, 86150
Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie
Bad Soden, Germany, 65812
Poliklinik am Paritätischen Krankenhaus
Berlin, Germany, 10365
Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie
Berlin, Germany, 10367
Oskar-Helene-Heim
Berlin, Germany, 14195
Praxis Drs. Marschner, Zeiss, Kirste
Freiburg, Germany, 79106
DRK-Krankenhaus
Luckenwalde, Germany, 14943
Praxis für Onkologie Dr.med. Siegfried Völkl
Munich, Germany, 80637
Praxis Drs. Kowolik/Prechtl
Munich, Germany, 81925
Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13
Nürnberg, Germany, 90419
Gemeinschaftspraxis Dr.med. Heinrich-Ekkerd Fiechtner
Stuttgart, Germany, 70173
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Universitätsklinikum Tübingen Medizinische Klinik 1
Tübingen, Germany, 72076
Gemeinschaftspraxis für internistische Onkologie
Velbert, Germany, 42551
Praxis für internistische Onkologie
Weiden, Germany, 92637
Romania
Oncologic Institute "Prof.Dr.I.Chiricuta" Cluj
Cluj-Napoca, Romania, 400015
Country hospital Oradea
Oradea, Romania, 410032
County Hospital Satu-Mare
Satu-Mare, Romania, 440192
Oncomed SRL Timisoara
Timisoara, Romania, 300239
Sponsors and Collaborators
Sandoz
Hexal AG
Investigators
Study Chair: Andrea Vetter, Dr. Hexal AG
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT00711958     History of Changes
Other Study ID Numbers: 2003-31-INJ-11 
Study First Received: July 3, 2008
Last Updated: October 21, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sandoz:
Chemotherapy associated anemia in cancer patients

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Pharmaceutical Solutions
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on December 07, 2016