A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoeisis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)
This study is currently recruiting participants.
Verified February 2013 by Pharmacosmos A/S
Sponsor:
Pharmacosmos A/S
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01145638
First received: June 15, 2010
Last updated: February 11, 2013
Last verified: February 2013
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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 Erythropoeisis 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: | January 2014 |
| Estimated Primary Completion Date: | June 2013 (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:
- Men and women, aged more than 18 years.
- 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.
- Hb < 12 g/dL (7.4 mmol/L).
- TfS <50%.
- Serum Ferritin <800 ng/ml.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- Willingness to participate after informed consent (including HIPAA, if applicable).
Exclusion Criteria:
- Anaemia caused primarily by other factors than CIA.
- IV or oral iron treatment within 4 weeks prior to screening visit.
- Erythrypoietin treatment within 4 weeks prior to screening visit.
- Blood transfusion within 4 weeks prior to screening visit.
- Imminent expectation of blood transfusion on part of treating physician.
- Iron overload or disturbances in enrolment of iron (e.g. haemochromatosis and haemosiderosis).
- Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate).
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
- Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALAT) > 3 times upper normal limit).
- History of Immunocompromise and/or history of Hepatitis B and/or C.
- 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)).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- 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).
- Planned elective surgery during the study.
- Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening.
- Known intolerance to oral iron treatment.
- Untreated B12 or folate deficiency.
- 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
Contacts
| Contact: Lars Lykke Thomsen | +45 59485959 | llt@pharmacosmos.com |
Locations
| India | |
| Apollo Hospitals | Recruiting |
| New Delhi, India | |
| Contact: Rakesh Chopra, MD | |
| Principal Investigator: Rakesh Chopra, MD | |
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: | February 11, 2013 |
| 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 |
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 Ferric Compounds Trace Elements Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013