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:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00711958
First received: July 3, 2008
Last updated: July 8, 2008
Last verified: July 2008
  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: HX 575 solution for injection (s.c.)
Drug: ERYPO®, Janssen-Cilag, Germany. 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 Novartis:

Primary Outcome Measures:
  • To assess the efficacy and safety of HX575 in the treatment of chemotherapy associated anemia [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and severity of all and of all drug related adverse events [ Designated as safety issue: Yes ]

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: 1
HX 575
Drug: HX 575 solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
Active Comparator: 2
ERYPO® Janssen-Cilag, Germany
Drug: ERYPO®, Janssen-Cilag, Germany. Solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Oskar-Helene-Heim
Berlin, Germany, 14195
Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie
Berlin, Germany, 10367
Poliklinik am Paritätischen Krankenhaus
Berlin, Germany, 10365
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
Novartis
Investigators
Study Chair: Andrea Vetter, Dr. Hexal AG
  More Information

No publications provided

Responsible Party: Hexal AG
ClinicalTrials.gov Identifier: NCT00711958     History of Changes
Other Study ID Numbers: 2003-31-INJ-11
Study First Received: July 3, 2008
Last Updated: July 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Romania: National Medicines Agency

Keywords provided by Novartis:
Chemotherapy associated anemia in cancer patients

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin alfa
Pharmaceutical Solutions
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014