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1 Clinical Trial Details (PDF Generation Date :- Wed, 12 Dec :35:45 GMT) CTRI Number Last Modified On 15/01/2013 Post Graduate Thesis Type of Trial Type of Study Study Design CTRI/2011/12/ [Registered on: 22/12/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group Trial Public Title of Study A Clinical study to assess the absorption and distribution properties of iron isomaltoside 1000 (Monofer ) administered by 500 mg IV bolus injection or 1000 mg intravenous infusion to subjects with non-haematological malignancies associated with Chemotherapy Induced Anaemia (CIA) Scientific Title of Study A Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer ) administered by 500 mg IV bolus injection or 1000 mg intravenous infusion to subjects with non-haematological malignancies associated with Chemotherapy Induced Anaemia (CIA) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) P-Monofer-PK-CIA-04 Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Sumbul Siddiqui Medical Monitor Affiliation Max Neeman International Phone Fax Affiliation Max Neeman International Max House, 1, Dr. Jha Marg, Okhla Phase-III, New Delhi, South DELHI ssiddiqui@neemanasia.com Details Contact Person (Public Query) Dr Shariq Anwar Director Operations Max Neeman International Max Neeman International Max House, 1, Dr. Jha Marg, Okhla Phase-III, New Delhi, South DELHI page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Pharmacosmos A/S Type of Sponsor Max Neeman International List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Pharmacosmos AS Roervangsvej 30, DK-4300 Holbaek,Denmark.USA Pharmaceutical industry-global Dr V Satya Suresh Attili Bibi general hospital & cancer centre Dr Ajay Mehta Dr Rajnish Nagarkar Dr Shailesh Bondarde Max House,1st Floor 1 Dr. Jha Marg, Okhla III New Delhi of Site Site Phone/Fax/ Central Cancer Research Institute Curie Manavata Cancer Center Shatabdi Super Speciality Hospital Consultant Department of Oncology Bibi general hospital & cancer centre, /1/c, govt. Printing press road, Malakpet,Hyderabad,Andhra Pradesh Country: Hyderabad ANDHRA PRADESH Consultant Department of Oncology, Central Cancer Research Institute, 11, Shankar Nagar,West High Court Road, Nagpur Maharashtra, ,. Nagpur Curie Manavata Cancer Center, 3rd Floor, Padma vishwa Regency, Opp. Mahamarg Bus Stand, Mumbai Naka, Pin Code Nashik Shatabdi Super Speciality Hospital, Suyojit City Centre, Opp.Mahamarg Bus Stand, Mumbai Naka, Pin Code , Nashik sureshattili@yahoo.com ajayonco@hotmail.com drrajnagarkar@yahoo.c o.in shaileshbondarde@yah oo.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Cancer Research Institute Ethics Committee, 11-Shankar Nagar,West High Court Road Nagpur , Maharashtra, Institutional Review Board, Bibi General Hospital & Cancer Centre, /1/c, Govt printing press road, Malakpet, Hyderabad , Andhra Pradesh Manavata Clinical Research Instittute Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik , Maharashtra, Shatabdi Hospital Ethics Committee,Suyojit City Centre, Opp.Mahamarg Bus Stand,Mumbai Naka, Nashik , Status Approved 09/07/2010 No Approved 04/10/2010 No Approved 31/03/2012 No Approved 23/03/2012 No Date Approved/Obtained 25/11/2011 Health Type Patients Condition Non-haematological malignancies associated with Chemotherapy Induced Anaemia (CIA) Type Details Intervention Iron isomaltoside 1000 (Monofer ) Intervention Iron isomaltoside 1000 (Monofer ) Comparator Agent NA NA Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria administered as 500 mg IV bolus injections Frequency :- Once Daily Duration:- Once in study. administered as 1000 mg IV infusions Frequency :- Once Daily Duration:- Once in study. 1.Men and women, aged more than 18 years. 2.Weight above 50 kg. 3.Subjects diagnosed with non-haematological malignancies (solid tumours only) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. 4.Hb 5.TfS 6.Serum Ferritin 7.An Eastern Cooperative Oncology page 3 / 5

4 Exclusion Criteria Details Group (ECOG) performance status of 0 to 2. 8.Willingness to participate after informed consent. Exclusion Criteria 1.Anaemia caused primarily by factors other 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 utilisation of iron (e.g. haemochromatosis and haemosiderosis). 7.Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). 8.Known hypersensitivity to any excipients in the investigational drug products. 9.Subjects with a history of multiple allergies. 10.Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit). 11.History of immunocompromise and/or history of Hepatitis B and/or C. 12.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)]. 13.Rheumatoid arthritis with symptoms or signs of active joint inflammation. 14.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 (5 days) of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 15.Planned elective surgery during the study. 16.Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. 17.Untreated Vitamin B12 or folate deficiency. 18.Any other medical condition that, in the opinion of 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. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Not Applicable Primary Outcome Outcome Timepoints To assess PK properties of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer ) in CIA subjects. Total serum iron pharmacokinetic parameters: AUC0-t, AUC, Cmax, tmax, Ke, and t1/2 at 30 minutes and 0 minutes predose, and at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours post dose Secondary Outcome Outcome Timepoints To establish the effect of iron isomaltoside 1000 Change in reticulocyte count from study drug page 4 / 5

5 Powered by TCPDF ( PDF of Trial Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary (Monofer ) on the reticulocyte count To establish whether any excretion takes place in the urine after IV administration of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer ) To assess other laboratory measures of iron status To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer ) Total Sample Size=16 Sample Size from =16 03/01/2012 No Date Specified Years=0 Months=4 Days=0 Not Applicable Completed None as yet administration to 8, 24, 48 and 72 hours Total Urine-iron pharmacokinetic variable sampled accumulatively during four time intervals following each dosing event: 0-8h, 8-24h, 24-48h, and 48-72h Concentration of haemoglobin (Hb), Ferritin, Total Iron Binding Capacity (TIBC) and TfS at pre-specified time points Adverse events, laboratory safety variable, physical examination, vital signs, and Electrocardiogram (ECG) This study is Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer ) administered by 500 mg Intravenous (IV) bolus injection or 1000 mg intravenous infusion to subjects with non?haematological malignancies (solid tumours only) associated with Chemotherapy Induced Anaemia (CIA) that will be conducted approximately 3 centers in. The primary objective of the study is: To assess PK properties of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer ) in CIA subjects The secondary objectives are: To establish the effect of iron isomaltoside 1000 (Monofer ) on the reticulocyte count To establish whether any excretion takes place in the urine after IV administration of higher doses (500 mg and 1000 mg) of iron isomaltoside 1000 (Monofer ) To assess other laboratory measures of iron status To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer ) page 5 / 5