Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients
Condition: Anemia
MeSH terms: Anemia
Intervention: HX575, solution for injection (s.c.); ERYPO®, Janssen-Cilag, solution for injection (s.c.)
Intervention description: 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin; 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chemotherapy associated anemia in cancer patients

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.
    

Eligibility 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