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1 Clinical Trial Details (PDF Generation Date :- Tue, 26 Feb :59:50 GMT) CTRI Number Last Modified On 26/11/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/09/ [Registered on: 03/09/2015] - Trial Registered Prospectively No BA/BE Randomized, Crossover Trial Bioequivalence study of Paclitaxel protein-bound particles for injectable 100 mg/vial of Cipla Ltd.,India with ABRAXANE for Injectable Manufactured for: Celgene Corporation Summit, USA in Metastatic Breast cancer patients after failure of Chemotherapy /relapse after prior Chemotherapy. A multicenter, open label, randomized, balanced, two treatment,two period, two sequence, two way crossover, single dose,bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial of Cipla Ltd.,India with ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) Manufactured for: Celgene Corporation Summit, USA in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) 15-VIN-258 Version 02 Date 16 Oct 2015 Name Designation Affiliation Address Protocol Number Details of Principal Investigator Dr Ashoka Kumar Singh Phone Fax Name Designation Affiliation Address Head Of the Department - Clinical Operations Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA Ahmadabad India Ashoka.Singh@veedacr.com Details Contact Person (Scientific Query) Dr Ashoka Kumar Singh Head Of the Department - Clinical Operations Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA Details Contact Person (Public Query) India Phone Fax Name Designation Affiliation Address Ashoka.Singh@veedacr.com Details Contact Person (Public Query) Dr Ashoka Kumar Singh Head Of the Department - Clinical Operations Veeda Clinical Research Pvt. Ltd. Veeda Clinical Research Pvt. Ltd. Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad NA page 1 / 10

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax > Cipla Ltd India Name Address Type of Sponsor Name NIL List of Countries India Name of Principal Investigator Dr Neeti Sharma Source of Monetary or Material Support Primary Sponsor Details Cipla Ltd India Clinical Research & Development,4th Floor North Block, LBS Marg Vikhroli(West)Mumbai Pharmaceutical industry-indian Address NIL Name of Site Site Address Phone/Fax/ Acharya Tulsi Regional Cancer Treatment & Research Institute Oncology, Acharya Tulsi Regional Cancer Treatment & Research Institute, S.P. Medical College, Bikaner , Rajasthan Bikaner RAJASTHAN ch.com Dr Basavraj Kadalge Aster Aadhar Hospital Oncology, Aster Aadhar Hospital (Prerana Hospital Ltd.), R.S.No.628, B, Ward, Near Shastri Nagar, KMT workshop, Kolhapur , Kolhapur com Dr V S N Rao City Cancer Centre , CVK St, Suryarao Pet, Vijayawada, Andhra Pradesh Krishna ANDHRA PRADESH Dr S Xavier Dr. GVN Cancer Institute Oncology, Dr. GVN Cancer Institute, No.46, Singarathope, Trichy , Tamilnadu Tiruchirappalli TAMIL NADU vsnrao@yahoo.co.in xavier_onco@yahoo.co m page 2 / 10

3 Dr K Velavan Erode Cancer Centre Oncology, Erode Cancer Centre, SH 96, Thindal, Erode , Tamil Nadu Erode TAMIL NADU Dr Krishna Kamble Dr Sandeep Tiwari Dr Rohan Bhise Dr Yogesh Anap Dr Sangeeta Jiwatani Dr Kirushna Kumar Government Medical College King George Medical College KLES Dr. Prabhakar Kore Hospital & MRC Kolhapur Cancer Centre Radiation Threrapy and Oncology, Government Medical College Nagpur, Nagpur , Nagpur General Surgery and oncology, King George Medical College,, Lucknow ,UP,India. Lucknow UTTAR PRADESH Oncology, KLES Dr. Prabhakar Kore Hospital & MRC, Nehru nagar, Belagavi-59010, Karnataka Belgaum KARNATAKA Oncology, Kolhapur Cancer Centre, R-S 238, Opposite Mayur Petrol Pump,Gokul Shirgao, Kolhapur , Kolhapur Mangal Anand Hospital Oncology, Mangal Anand Hospital, 48, Swastik Park, Sion-Trombay Road, Chembur, Mumbai , Mumbai Meenakshi Mission Hospital Oncology,Meenakshi Mission Hospital, Lake Area, melur Road,, Madurai Nadu , Tamilnadu Madurai TAMIL NADU kvels@rediffmail.com drkamble.onco@gmail. com sandeep-neelu@yahoo. co.in rohanbhise30@gmail.c om yogesh.anap1@gmail.c om sangeetajiwatani@hotm ail.com drkskk@yahoo.com page 3 / 10

4 Dr Kaushal Patel Nirmal Hospital Oncology, Nirmal Hospital, Ring road, Surat , Gujarat Surat Dr Jitendra Kumar Singh S S Hospital and Research Centre oncology, S S Hospital and Research Centre, Doctor s Colony,Malahi Pakri Chowk, Kankarbagh, Patna Patna BIHAR Dr Vinayak Shenage Shatabdi Hospital Oncology, Shatabdi Hospital, Opp Mahamarg Bus Stand, Mumbai Naka, Nashik , Mumbai Dr Jignesh Meva Dr Lokesh K N Dr Sudha Somappa Dr Rakesh Neve Shree Giriraj Multispeciality Hospital Sri Venkateshwara Hospital Srinivasam Cancer Care Hospital Pvt. Ltd Sterling Multispeciality Hospital Oncology, Shree Giriraj Multispeciality Hospital, 27, Navjyot Park corner, 150 ft Ring Road. Rajkot , Gujarat Rajkot Oncology, Sri Venkateshwara Hospital, No. 86, madiwala, hosur Main Road, Bangalore , Karnataka Bangalore KARNATAKA Oncology, Srinivasam Cancer Care Hospital Pvt. Ltd, #236/vijayshree Layout Arelare, Bannergatta Main Road, Bangalore , Karnataka Bangalore KARNATAKA Oncology, Sterling Multispeciality Hospital, Sector 27, Near Bhel Chowk, Pradhikaran, Nigdi, Pimpri-Chinchwad, drkaushalbpatel@gmail.com drjksingh147@hotmail.c om drvinayakshenage@ya hoo.com drjigneshmeva@gmail.c om svhospital1997@gmail. com sudhasomappa@gmail. com drrneve@gmail.com page 4 / 10

5 Details of Ethics Committee Dr Hitendra Ayre Unique Hospital Multispecialty & Research Institute Pune , Pune oncology, Unique Hospital Multispecialty & Research Institute, Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off. Ring Road, Surat , Gujarat Surat Dr Shravan Tungenwar United CIIGMA Institute of Medical Sciences Pvt Oncology, United Ltd CIIGMA Institute of Medical Sciences Pvt Ltd, Plot No. 6 & 7, Plot no. 10, Shahnoorwadi dargah road, Aurangabad , Aurangabad Dr Mahesh Naik Vintage Hospital & Medical Research Centre Pvt. Ltd Hitendra_ayre@yahoo. com drshravan.uch@gmail.c om Oncology, Vintage Hospital & Medical drmaheshrnaik@gmail. Research Centre Pvt. com Ltd, Caculo Enclave, St. Inez, Panaji , Goa North Goa GOA Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Aster Aadhar Ethics Committee situated at Aster Aadhar Hospital BSES Municipal General Hospital Ethics Committee Dr. GVN Cancer Institute Institutional Sterling Hospital, KLE University, Kodlikeri memorial hospital and CIIGMA hospital, S.P Medical College & A.G Hospitals HRMC Approved 31/08/2015 No Approved 24/08/2015 No Approved 02/09/2015 No Approved 21/08/2015 No Approved 01/12/2015 No Approved 01/10/2015 No Submittted/Under Review No Date Specified No page 5 / 10

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Cardiovascular Sciences & Research Centre, Unique Hospital Multispeciality and Research Institute Committee - City Cancer Centre Committee Erode Cancer Centre Submittted/Under Committee S S Hospital Review and Research Centre Committee, Dept of Pharmacology, Govt Medical College Committee, Kings Georges Medical College Committee, Meenakshi Mission Hospital Committee, Srinivasan Cancer Care Hospital India Kohlapur Cancer Center Intitutional Nirmal Hospital Private Ltd Shatabdi Hospital Shree Giriraj Hospital Sri Venkateshwara Hospital Ethics Committee Vintage Institutional Status Approved 07/08/2015 No Approved 05/03/2016 No Approved 24/08/2015 No Submittted/Under Review No Date Specified No Date Specified No No Approved 02/11/2015 No Approved 20/08/2015 No Approved 25/08/2015 No Approved 23/09/2015 No Approved 03/09/2015 No Approved 07/09/2015 No Approved 31/08/2015 No Approved 07/08/2015 No Approved 20/08/2015 No Date No Objection Certificate 21/08/2015 Health Type Condition Patients Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Type Name Details Comparator Agent Abraxane for injectable suspension (Paclitaxel Manufactured for: Celgene Corporation Summit, USA page 6 / 10

7 Inclusion Criteria Intervention Age From Age To Gender Details protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial Paclitaxel protein-bound particles for injectable suspension (albuminbound) 100 mg/vial Year(s) Year(s) Female Inclusion Criteria Patients will receive 260mg/m2 dose of the study drug on the first day of the chemotherapy cycle [as per the randomisation sequence] for study duration 2 cycles Dose- 260 mg/m2, Frequency- In every 21 days (1 cycle), Mode of Administration-IV Manufactured by Cipla Ltd., India Patients will receive 260mg/m2 dose of the study drug on the first day of the chemotherapy cycle [as per the randomisation sequence] for study duration 2 cycles Dose- 260 mg/m2, Frequency- In every 21 days (1 cycle), Mode of Administration-IV 1. Female patients, 18 to 65 years of age (both inclusive). 2. Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic diseasem or has had a relapse within 6 months of adjuvant chemotherapy (Prior therapy should have included an anthracycline unless clinically contraindicated.). 3. Patients with life expectancy of at least 3 months as per the investigator opinion. 4. ECOG performance status of less and equal to Adequate hemopoeitic, renal and liver function. Bone marrow function: ANC more than and equal to 1500/mm3, Platelet count more than and equal to 100,000/mm3 Hemoglobin more than and equal to 9.0 g/dl Renal function Serum Creatinine more than 1.5 times ULN Hepatic function: AST and ALT less than and equal to 2.5 times ULN Alkaline phosphatase less than 2 times ULN Bilirubin less than and equal to 1.5 times ULN 6. All other clinical laboratory values deemed as not clinically significant by the Principal Investigator/Sub-Investigator. 7. Availability for the entire study duration and willingness to adhere to the protocol requirements. 8. Capable of giving written informed consent prior to receiving any study medication. 9. Women of childbearing potential must have a negative serum pregnancy test, must be using an adequate method of contraception and must be willing to avoid becoming pregnant during the study period. Female patients must fulfill at least one of the following: Be surgically sterile for a minimum of 6 months; Post-menopausal for a minimum of 1 year; Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days page 7 / 10

8 Exclusion Criteria Details after the study has ended (last study procedure). Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).complete abstinence alone can be used as a method of contraception. Exclusion Criteria 1. History of allergy or hypersensitivity reactions to a Paclitaxel or the components of Paclitaxel protein-bound particles for injectable suspension(albumin-bound) or any related compound at any dose. 2. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological (e.g., bleeding diathesis or coagulopathy) disease or condition other than cancer unless determined as not clinically significant by the Investigator. 3. History of any other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer. 4. Sensory / Peripheral neuropathy of more than Grade 2 at baseline. 5. Presence of any significant physical or organ abnormality or active opportunistic infection (i.e. mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii) as determined by the Investigator. 6. Patients not completely recovered from any toxicities from previous chemotherapy, hormonetherapy, immunotherapy, or radiotherapies less than or equal to Grade A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse and breath alcohol test. 8. Difficulty fasting or consuming standard meals. 9. Patients who are: Pregnant Breast feeding Of childbearing potential without a negative pregnancy test at baseline Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery. Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent 10. Known history or presence of: Alcohol abuse or dependence within one year prior to first drug administration; Drug abuse or dependence; Severe allergic reactions (e.g. anaphylactic reactions, angioedema) 11. History of difficulty with donating blood or difficulty in accessibility of veins. 12. Any clinically significant abnormal findings in 12 lead ECG, 2D ECHO, X-ray findings, as judged by investigator. 13. Patient is taking inhibitor, or inducer of CYP2C8 or CYP3A4 enzymes and in whom these drugs are unable to be restricted for the entire study period.(annexure IV) 14. Any other condition, that in the investigator s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory page 8 / 10

9 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Other Open Label data needed to achieve the objectives of the study. 15. Participation in any clinical study, chemotherapy and/ or radiotherapy within the past 30 days of first IMP administration or has not recovered from the side effects of previous therapy or has less than 5 washout periods from previous therapy. Primary Outcome Outcome Timepoints - To compare and evaluate the single dose bioavailability of Paclitaxel protein-bound particles for injectable suspension(albumin-bound) 100 mg/vial of test and refernce product - To monitor the adverse events and to ensure the safety of patients. A total of 20 blood samples will be collected during each period. The pre-infusion blood sample of 4.0 ml (00.00) will be collected within 5 minutes prior to the dosing. The post-dose blood samples of 4.0 ml each will be withdrawn. After start of intravenous Infusion, blood samples 4.0 ml each will be collected at (5 min), (10 min), (20 min), (25 min), 0.50 (30 min), (35 min), 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 hours. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary To monitor the adverse events and to ensure the safety of patients. Total Sample Size=96 Sample Size from India=96 N/A 15/09/2015 No Date Specified Years=0 Months=9 Days=0 Not Applicable Closed to Recruitment of Participants NA This is a multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial of Cipla Ltd., India with ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) Manufactured for: Celgene Corporation Summit, USA in Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. NA Treatments will be allocated to patient by carrying out randomization using statistical techniques. During the treatment phase, each patient will receive a total of 1 dose of the reference drug and 1 dose of the test drug; patients will be randomly allocated to the sequence in which they receive study drug (i.e., reference drug then test drug or test drug then reference drug). The reference or test drug will be administered as a 30-minute intravenous infusion on Day 1 of each treatment period. Dosing in each period will be separated by at least 21 page 9 / 10

10 Powered by TCPDF ( days. During each treatment period, serial blood samples will be collected at various time-points. Patients will remain in the clinical research unit till 48 hours post-dose. Pharmacokinetic sample will be collected up to 48 hours after the start of the infusion. Total of 20 blood samples will be collected during each period. The pre-infusion blood sample of 4.0 ml (00.00) will be collected within 5 minutes prior to the dosing. The post-dose blood samples of 4.0 ml each will be withdrawn. After start of intravenous Infusion, blood samples (1 x 4.0 ml each) will be collected at (5 min), (10 min), (20 min), (25 min), 0.50 (30 min), (35 min), 0.75 (45 min), 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours. page 10 / 10