A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01145638
First received: June 15, 2010
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.


Condition Intervention Phase
Non-myeloid Malignancies
Chemotherapy Induced Anaemia
Drug: iron isomaltoside 1000
Drug: iron sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Change in Hb concentration [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of study drug related adverse events (including serious adverse reactions) in iron isomaltoside 1000 (Monofer®) group and iron sulfate group. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: October 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iron isomaltoside 1000
Iron isomaltoside intravenously as bolus or infusion
Drug: iron isomaltoside 1000
intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
Other Name: Monofer
Active Comparator: iron sulphate
oral iron sulphate twice a day
Drug: iron sulphate
oral, 200 mg per day (100 mg bid),12 weeks
Other Name: Ferroduretter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, aged more than 18 years.
  2. Subjects diagnosed with cancer (non-myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles.
  3. Hb < 12 g/dL (7.4 mmol/L).
  4. TfS <50%.
  5. Serum Ferritin <800 ng/ml.
  6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
  7. Willingness to participate after informed consent (including HIPAA, if applicable).

Exclusion Criteria:

  1. Anemia caused primarily by other factors than CIA.
  2. IV or oral iron treatment within 4 weeks prior to screening visit.
  3. Erythropoietin treatment within 4 weeks prior to screening visit.
  4. Blood transfusion within 4 weeks prior to screening visit.
  5. Imminent expectation of blood transfusion on part of treating physician.
  6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
  7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
  8. Known hypersensitivity to any excipients in the investigational drug products.
  9. Subjects with a history of multiple allergies.
  10. Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
  11. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)).
  12. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  13. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
  14. Planned elective surgery during the study.
  15. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
  16. Known intolerance to oral iron treatment.
  17. Untreated B12 or folate deficiency.
  18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145638

Locations
India
Apollo Hospitals
New Delhi, India
Sponsors and Collaborators
Pharmacosmos A/S
Investigators
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01145638     History of Changes
Other Study ID Numbers: P-Monofer-CIA-01, EudraCT no. 2009-016727-53
Study First Received: June 15, 2010
Last Updated: January 30, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: The Drugs Controler India
Sweden: Medical Products Agency
Germany: BundesInstitut Für Arsneimittel und Medizinprodukte
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Russia: The Ministry of Health of the Russian Federation
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
USA: The Food and Drug Administration

Keywords provided by Pharmacosmos A/S:
cancer
chemotherapy induced anaemia
iron
Patients with non-myeloid malignancies and Chemotherapy Induced Anaemia (CIA)
CIA

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Iron
Hematinics
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014