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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711958
• Other study ID #: 2003-31-INJ-11
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2008
• Last updated: October 21, 2016
• Start date: November 2004
• Est. completion date: December 2005

Study information

• Verified date: October 2016
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• HX575, solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin
• ERYPO®, Janssen-Cilag, solution for injection (s.c.)
1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

Locations

Country	Name	City	State
Germany	Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter	Augsburg
Germany	Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie	Bad Soden
Germany	Oskar-Helene-Heim	Berlin
Germany	Poliklinik am Paritätischen Krankenhaus	Berlin
Germany	Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie	Berlin
Germany	Praxis Drs. Marschner, Zeiss, Kirste	Freiburg
Germany	DRK-Krankenhaus	Luckenwalde
Germany	Praxis Drs. Kowolik/Prechtl	Munich
Germany	Praxis für Onkologie Dr.med. Siegfried Völkl	Munich
Germany	Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13	Nürnberg
Germany	Gemeinschaftspraxis Dr.med. Heinrich-Ekkerd Fiechtner	Stuttgart
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Germany	Universitätsklinikum Tübingen Medizinische Klinik 1	Tübingen
Germany	Gemeinschaftspraxis für internistische Onkologie	Velbert
Germany	Praxis für internistische Onkologie	Weiden
Romania	Oncologic Institute "Prof.Dr.I.Chiricuta" Cluj	Cluj-Napoca
Romania	Country hospital Oradea	Oradea
Romania	County Hospital Satu-Mare	Satu-Mare
Romania	Oncomed SRL Timisoara	Timisoara

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Hexal AG

Countries where clinical trial is conducted

Germany,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Safety of HX575 in the treatment of chemotherapy associated anemia	Incidence and severity of all and of all drug related adverse events	12 weeks	Yes