PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Wed, 14 Nov :18:14 GMT) CTRI Number Last Modified On 02/10/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/04/ [Registered on: 11/04/2013] - Trial Registered Retrospectively No BA/BE Randomized, Crossover Trial This is comparative study for the Imatinib Mesylate 400mg tablets with Imatinib Mesylate 400mg tablets of (GLIVEC )Novartis Europharm Limited, United Kingdom in patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition. A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, multiple dose, comparative oral bioavailability study of Imatinib mesylate tablets 400mg of Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), with GLIVEC (Imatinib Mesylate) tablets 400 mg film coated tablets marketed by Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) 12-VIN-108 Version 01 dated 30 March 2012 Designation Affiliation Protocol Number Details of Principal Investigator Dr Brijesh Wadekar Head of Department Phone Fax Designation Affiliation Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Ahmadabad brijesh.wadekar@veedacr.com Details Contact Person (Scientific Query) Dr Brijesh Wadekar Head of Department Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Details Contact Person (Public Query) Phone Fax brijesh.wadekar@veedacr.com Details Contact Person (Public Query) Dr Brijesh Wadekar page 1 / 6

2 Designation Affiliation Head of Department Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd.Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Insignia, sindhu Bhavan Road, Bodakdev Road, S.G.highway, Ahmedabad Gujarat Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Onco Therapies Limited (A subsidiary of Strides Arcolab Ltd) Type of Sponsor Veeda clinical research Pvt Ltd List of Countries of Principal Investigator Dr Sandeep Madhopati Dr Tanveer Maksud Dr AVS Suresh Primary Sponsor Details Onco Therapies Limited which is a subsidiary of Strides Arcolab Ltd Bilekahalli, Bannerghatta Road, Bangalore ,. Pharmaceutical industry-n Veeda clinical research Pvt. Ltd Shivalik Plaza, Near I.I.M., Ambawadi, Ahmedabad , of Site Site Phone/Fax/ Belgaum Cancer Hospital Pvt. Ltd Bharat Cancer Hospital and Research Institute BIBI General Hospitals & Cancer Centre Belgaum Cancer Hospital Pvt. Ltd., 9666A-2/D, Ashok Nagar, Belgaum Belgaum KARNATAKA Manavdaya Trust Complex, Surat- bardoli Road, Saroli Road, Saroli Surat /1/C, Govt Printing Press Road, Malakpet, Hyderabad, AndhraPradesh Hyderabad ANDHRA PRADESH Dr SPShrivastav Life Research Centre 401, Param Doctor House, Station to lal Darwaja Road, Surat Surat Dr Asis Mukhopadhyay Netaji Subhash Chandra Bose Cancer Netaji Subhash Chandra Bose Cancer tanveermaksud@yahoo.com sureshattili@yahoo.com crconcolrc@yahoo.com page 2 / 6

3 Details of Ethics Committee Research Institute Research Institute,16A,Park lane,kolkata Kolkata WEST BENGAL Dr SS Nirni Omega Hospital Omega Hospital,MLA Colony Main road, Road No.-12,Banjara Hills, Hyderabad ,Andhra Pradesh,. Hyderabad ANDHRA PRADESH Dr C T Satesh Dr Shekhar Salkar Srivenkateshwara hospital Vintage Hospital and Medical Research Centre Srivenkateshwara hospital,#86,hosur main road,madiwala,ba nglore,karnataka Bangalore KARNATAKA Caculo Enclave, St. Inez, Panjim, Goa North Goa GOA ncri.clinicalresearch@g mail.com nirni2002@rediffmail.co m svhospitalresearch@g mail.com cromgoa@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Banglore Ethics Commi tttee/banglore/dr.c.sat heesh DAKSH INDEPENDENT ETHICS COMMITTEE/ HYDERABAD/DR. S S NIRNI Approved 17/11/2012 No Approved 01/11/2012 Yes Ethics Commitee Belgaum Diabetes Cent re/belgaum/dr.sandee p Approved 19/11/2012 No Ethics Committee Netaji Approved 05/11/2012 No Subhash Chandra Bose Cancer Research Institute/Kolkata/Dr.Asis Mukhopadhyay Institutional Ethics Committee BIBI General Hospital and Cancer Centre/hyderabad/Dr. V. Satya Suresh Attili Research Independent Ethics Committee/Surat /Dr.Maksud Approved 03/09/2012 No Approved 03/09/2012 Yes Research Independent Approved 03/09/2012 Yes Ethics Committee/surat/ Dr.S.P.Shrivastav Vintage Ethics Committ ee/goa/dr.shekhar Approved 01/10/2012 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Status Date Notified 27/08/2012 Health Type Patients Condition Chronic Myeloid Leukemia Type Details Intervention Comparator Agent Age From Age To Gender Details Details Imatinib mesylate tablets 400mg tablet once daily GLIVEC Imatinib mesylate 400mg tablet once daily Year(s) Year(s) Both Inclusion Criteria Onco Therapies Limited (a subsidiary of Strides Arcolab Ltd.), marketed by Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom 1. Men and women, 18 years of age or older. 2. Ability to provide written informed consent prior to participation in the study 3. Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception. 4. Patients with Chronic Phase Ph+ CML who are on stable dose regimen of 400mg daily dose And/Or Gastrointestinal Stromal Tumor (GIST) who are on a stable dose regimen of 400 mg daily dose 5. Documented chronic phase CML as defined by: blood and bone marrow? 100 x 10 to the power of 9/L (? 100,000 /mm cube) platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly 6. Adequate organ function, defined as the following: total bilirubin (ULN) SGOT and SGPT Creatinine Absolute neutrophil count (ANC) > 1.5 x 10 to the power of 9/L Platelets > 100 x 10 to the power of 9/L 7. Patients for whom a titration away from 400 mg dose is unlikely, such as patients with gastrointestinal stromal tumors and patients in their first three months of treatment for chronic myeloid leukemia (CML). 8. No history of addiction to any recreational drug or drug dependence 9. No participation in any clinical study within the past 90 days Exclusion Criteria 1. Patients in accelerated phase or blastic phase are excluded 2. Patients who require greater than 400mg daily dose of Imatinib 3. Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide 4. Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention page 4 / 6

5 5. Patients who are: Pregnant Breast feeding Of childbearing potential without a negative pregnancy test prior to baseline Male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery Patients with an ECOG Performance Status Score greater than equal to 3 Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) greater than 1.5 x IULN, with the exception of patients on treatment with oral anticoagulant Patients with known positivity for human immunodeficiency virus (HIV) Patients with any significant history of noncompliance to medical regimens or with inability to grant a reliable informed consent Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment Taking CYP3A4 inhibitors and/or inducers Having History of Hematopoietic stem cell transplantation. 6.Intolerance to Imatinib at any dose. 7.Subjects who are eligible and willing to undergo transplantation during the screening period. 8.Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes. 9.Subjects taking medications that irreversibly inhibit platelet function or anticoagulants. 10.Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure, neuropsychiatric infection or disease. 11.History of Alcohol and/or drug addiction. 12.History of accelerated or blast phase CML 13.With history of ascites and rapid weight gain with or without superficial edema 14.Grade 3 or 4 neutropenia and thrombocytopenia 15.Uncontrolled diabetes mellitus 16.History of hematopoietic stem cell transplantation. 17.Prior radiotherapy to bone marrow 18.Major surgery within 4 weeks of enrolment.. 19.Use of other concurrent anticancer agents, including chemotherapy or biologic agents. 20.Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids cocaine and barbiturates) in urine 21.Positive results for alcohol as detected by Alcohol Breath Analyzer. 22.History of difficulty with donating blood or difficulty in accessibility of veins. 23.An unusual or abnormal diet, for whatever reason e.g. religious fasting. 24.High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/ beedies/ cigars per day) consumption. Method of Generating Random Sequence Other page 5 / 6

6 Powered by TCPDF ( PDF of Trial Method of Concealment Blinding/Masking An Open list of random numbers Open Label Primary Outcome Outcome Timepoints To compare and evaluate the multiple-dose oral The pre-dose blood sample of 3.0mL (00.00) bioavailability of Imatinib mesylate tablets 400mg will be collected within one hour prior to the of Onco Therapies Limited (a subsidiary of dosing time on Strides day 1. The pre-dose blood sample on Day 6 to Arcolab Ltd.), with GLIVEC (Imatinib day 8 and on Mesylate) tablets 400 mg film coated tablets of Day 9, Day 14 to 16 will be collected within 5 Novartis Europharm Limited, Wimblehurst Road, minutes Horsham, West Sussex, RH12 5AB, United before dosing time. On day 8 and 16, the Kingdom in adult human patients with Chronic post-dose blood Myeloid Leukemia and/or Gastrointestinal samples of 3.0mL each will be drawn at 0.5, StromalTumor under fed steady-state condition 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, and hrs following drug administration in each period. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial 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 To monitor the adverse events and to ensure the safety of Patient Total Sample Size=32 Sample Size from =32 N/A 12/11/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable Completed To compare and evaluate the rate and extent of absorption of Imatinib Mesylate 400 mg tablets of Onco therapies Ltd (A subsidiary of Strides Arcolab Ltd) with Glivec (Imatinib Mesylate) tablets marketed by Novartis Europharm Limited United Kingdom in adult human patients with Chronic Myeloid Leukemia and/or Gastrointestinal Stromal Tumor under fed steady-state condition. N/A page 6 / 6