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Trial record 9 of 36 for:    pharmacosmos

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)

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ClinicalTrials.gov Identifier: NCT01145638
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE June 16, 2010
Results First Submitted Date  ICMJE September 21, 2015
Results First Posted Date  ICMJE December 3, 2015
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Change in Hb Concentration [ Time Frame: Baseline week 4 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Change in Hb Concentration [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01145638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Change in Hemoglobin From Baseline to Week 24 [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2010)
Number of study drug related adverse events (including serious adverse reactions) in iron isomaltoside 1000 (Monofer®) group and iron sulfate group. [ Time Frame: Baseline, 12 and 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-myeloid Malignancies
  • Chemotherapy Induced Anaemia
Intervention  ICMJE
  • Drug: iron isomaltoside 1000
    intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
    Other Name: Monofer
  • Drug: iron sulphate
    oral, 200 mg per day (100 mg bid),12 weeks
    Other Name: Ferroduretter
Study Arms  ICMJE
  • Experimental: iron isomaltoside 1000
    Iron isomaltoside intravenously as bolus or infusion
    Intervention: Drug: iron isomaltoside 1000
  • Active Comparator: iron sulphate
    oral iron sulphate twice a day
    Intervention: Drug: iron sulphate
Publications * Birgegård G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial. Pharmacotherapy. 2016 Apr;36(4):402-14. doi: 10.1002/phar.1729. Epub 2016 Apr 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2010)
350
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries Denmark,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01145638
Other Study ID Numbers  ICMJE P-Monofer-CIA-01
EudraCT no. 2009-016727-53
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S
PRS Account Pharmacosmos A/S
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP