Clinical Trial Details (PDF Generation Date :- Sat, 17 Nov 2018 21:22:46 GMT) CTRI Number Last Modified On 29/08/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/11/002104 [Registered on: 04/11/2011] - Trial Registered Prospectively No BA/BE Randomized, Crossover Trial This is a comperative study for the Etoposide 50 mg capsules manufactured with Etoposide 50 mg capsules of Mylan Inc. USA, in patients with small cell lung cancers under fasting condition. A randomized, multiple site, open label, two treatment, two period, two sequence, multiple-dose, crossover, bioequivalence study of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) 10-VIN-195 Version:01 Dated:1-July-2011 Protocol Number Details of Principal Investigator Phone 079-30013000 Fax 079-30013010 Veeda Clinical Research Pvt. Ltd. Bodakdev road, S. G. Highway, Ahmedabad Veeda Clinical Research Pvt. Ltd., Insignia, Sindhu Bhavan Road, Bodakdev road, S. G. Highway, Ahmedabad Ahmadabad Details Contact Person (Scientific Query) Bodakdev road, S. G. Highway, Ahmedabad Details Contact Person (Public Query) Phone Fax Details Contact Person (Public Query) Bodakdev road, S. G. Highway, Ahmedabad page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Banner Pharmacaps, USA Type of Sponsor NIL List of Countries of Principal Investigator Source of Monetary or Material Support Primary Sponsor Details Banner Pharmacaps Banner Pharmacaps 4125 Premier Dr, High Point, NC 27265, United states of America Phone: 336-812-8700 Fax: 336-812-9091 Pharmaceutical industry-global Dr Ajay Mehta Central Cancer Research Institute Dr G N Patel Dr Niraj Bhatt NIL of Site Site Phone/Fax/ Jeevandeep Oncosurgical Hospital Kailash Cancer Hospital and Research Centre 11, shankar Nagar, Nagpur 440010 Maharastra Nagpur MAHARASHTRA Jeevandeep Oncosurgical Hospital, 302, 3rd floor, Ayush building, Near Param Doctor House, Laldarwaja-Station Road, Surat. Surat Chemotherapy Day care Unit, ground floor, Muni Seva Ashram, Goraj, Dist: Vadodara 391760, Gujarat, Vadodara Dr SPShrivastav Life Research Centre 401, Param Doctor House, Station Lal Darwaja Road, Surat 395003 Ahmadabad Dr J K Singh Mahavir Cancer Sansthan Room no 222, 2nd floor, Magadh Clinical Research, Phulwarisharif, Patna-801505, Bihar Patna BIHAR 9823190192 ajayonco@hotmail.com 9376913131 gnonco@gmail.com 9925581480 medonc12@gmail.com 2612242862 crconcolrc@yahoo.com 9431021001 drjksingh147@gmail.co m Dr Yathish kumar NRR Hospital NRR hospital OPD, 9880462912 page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent First Floor, NRR Hospital, 3 & 3A, Hesaraghatta main road, Chikkasandra Near Chikkabanabara railawya station, Bangalore 560090 Bangalore KARNATAKA Dr Ramesh Arya Suyash Hospital AB road, Opposite MGM Medical College, Indore Indore MADHYA PRADESH Dr Shekhar Salkar Vintage Hospital and Research Centre Caculo Enclave, St. Inez, Panaji, Goa 403001 North Goa GOA dryathish@hotmail.com 73140456206 draryaramesh@gmail.c om 8322363831 salkar.shekhar@gmail.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? Anveshhan Independent Ethics Committee (Ahmedabad)- Dr. Neeraj Bhatt Central Cancer Research Institute (Nagpur)- Dr. Ajay Mehta Ethical Review Board, Mahavir Cancer Institute and Research Centre (Patna) - Dr. J. K. Singh Ethical Trial of Health In Community (ETHIC) Committee (Surat)- Dr. G. N. Patel Indore Independent Institutional Ethics Committee, NRR Hospital (Banglore)- Dr. Yathish Kumar HM Research Independent Vintage Institutional Status Approved 02/08/2011 Yes Approved 31/07/2011 No Approved 03/08/2011 No Approved 18/07/2011 Yes Approved 18/07/2012 Yes Approved 23/07/2011 No Approved 16/07/2012 Yes Approved 04/07/2012 No Date Notified 09/09/2011 Health Type Patients Condition Cancer Patients Type Details Comparator Agent Etoposide 50 mg Capsule DOSE:50 mg/m2/day for 5 days page 3 / 5
Inclusion Criteria DURATION: 1 cycles FREQUENCY: Every 21 Days MODE OF ADMIN: Oral Intervention Etoposide 50 mg capsules DOSE:50 mg/m2/day for 5 days DURATION: 1 cycle FREQUENCY: Every 21 Days MODE OF ADMIN: Oral Age From Age To Gender Details 18.00 Year(s) 75.00 Year(s) Both Inclusion Criteria Male or female patients aged 18years of age or older. Patients already receiving etoposide and expected to receive at least two additional cycles at the same dose. Eastern Cooperative Oncology Group (ECOG) performance status Life expectancy > 3 months. Exclusion Criteria Details Exclusion Criteria The patients will be excluded from study, if they meet any of the following criteria: Hypersensitivity to Etoposide or related class of drugs. Extensive disease treatable with radiotherapy. Past or current history of other malignant disease. Concurrent severe medical problems other than small cell lung cancer. Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms. Patient had a clinically significant history of cardiac disease; Patient had pre-existing severe motor or sensory neuropathy higher than grade 1, according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (34); had active infections or other serious concomitant medical conditions that would impair the ability of a patient to receive the protocol treatment; Patients with low serum albumin. Patient had dementia. Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study. Women using a prohibited contraceptive method. Women who are pregnant or breastfeeding. Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above. Known CYP450 strong inhibitors2 such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir or telithromycin and well known inducers2 such as rifampin, carbamazepine, rifabutin, rifapentin, dexamethasone, phenytoin, phenobarbital, and St. Johns wort within 1 month of the study starting. History or presence of significant alcoholism or drug abuse in the past one year. History or presence of significant smoking (more than 10 cigarettes or beedi s/day). History or presence of asthma, urticaria or other significant allergic reactions. History or presence of significant gastric and/or duodenal ulceration. page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. Difficulty with donating blood. Difficulty in swallowing solids like tablets or capsules. Patients with any other condition which in the Investigators opinion would not make the patient a good candidate for the clinical trial. Severe medical problems other than the cancer that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk. Participation in a drug research study within past 3 months. Donation of blood in the past 3 months before screening. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. History or presence of significant easy bruising or bleeding. History or presence of significant recent trauma. Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Not Applicable Open Label Primary Outcome Outcome Timepoints To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions. The pre-dose blood sample of 3.5mL (0.00 hr) will be collected within 5 minutes prior to dosing time on Day 3, 4 and 5. On Day 5 the post-dose blood samples of 3.5mL each will be drawn at 15, 20, 30, 45 and 60 mins and then 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, and 48.00 hrs following drug administration in each period. Secondary Outcome Outcome Timepoints To monitor the adverse events of Etoposide and to ensure the safety of patients. N/A 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 Total Sample Size=24 Sample Size from =24 N/A 02/01/2012 No Date Specified Years=1 Months=0 Days=0 Not Applicable Open to Recruitment Brief Summary Primary Objective : To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions. page 5 / 5