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1 Clinical Trial Details (PDF Generation Date :- Tue, 13 Nov :55:18 GMT) CTRI Number Last Modified On 11/08/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/01/ [Registered on: 30/01/2017] - Trial Registered Prospectively No BA/BE Randomized, Crossover Trial To compare bioavailability of Paclitaxel protein-bound particles of Cipla Ltd.,India with ABRAXANE in Metastatic Breast cancer patients. A multicenter, open label, randomized, two treatment, two period, two way crossover, single dose, bioequivalence study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial by Celgene Corporation, 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) Details Contact Person (Public Query) CRD/09 - Ver 01 dated 12 Aug 2016 Designation Affiliation Protocol Number Details of Principal Investigator Dr Shailesh Bondarde Principal Investigator Phone Fax Designation Affiliation Shatabdi Superspecialty Hospital, Suyojit City Centre, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik Nashik India shaileshbondarde@yahoo.com Details Contact Person (Scientific Query) Dr Sougat Sarkar Medical & Safety Expert Cipla Ltd. Phone Fax Designation Affiliation Cipla Ltd., Clinical Research and Development, R&D Center, 4th Floor, North Block, LBS Marg, Vikhroli West. Mumbai India sougat.sarkar@cipla.com Details Contact Person (Public Query) Monica Razdan Lead Project Manager Cipla Ltd. Cipla Ltd., Clinical Research and Development, R&D Center, 4th Floor, North Block, LBS Marg, Vikhroli West. Mumbai page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study India Phone Fax Source of Monetary or Material Support > Cipla Ltd., R&D centre, LBS Marg, Vikhroli (W), Mumbai , India. Type of Sponsor NIL List of Countries India of Principal Investigator Cipla Ltd Primary Sponsor Details LBS Marg, Vikhroli West, Mumbai , Maharashtra Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Dr Jayanti Patel Apple Hospital Dept. of Medical Oncology, First Floor, Udhna Darwaja, Ring Road, Surat, Gujarat , India Surat GUJARAT Dr H D Jayanthi BGS Global Hosptal BGS Health and Education City, 5th Floor, 67 Uttarahalli, Main Road, Kengeri, Sukalapalya, Bangaluru, Karnataka Bangalore KARNATAKA Dr Ajay Mehta Central India Cancer Ground Floor, Dr Mehtas Cabin, Plot # 11, Shankar Nagar, West High Court Road, Nagpur Maharashtra, India. Nagpur pateldrjayanti@gmail.co m drjayanthisthumsi@gm ail.com ajayonco@hotmail.com Dr M Gopichand City Cancer Centre Ground floor, Consultation room #1, # , Ch. Venkata mgopichand@yahoo.co Krishnayya street, m Suryarao pet, Vijayawada, Andhra Pradesh , India. Krishna ANDHRA PRADESH Dr Rajnish Nagarkar Curie Manavata Cancer Centre Ground Floor, OPD No. 1, Curie Manavata Cancer Centre drraj@manavatacancer page 2 / 8

3 Dr Ravi Kumar Saxena Dr Minish Jain Dr Radheshyam Naik Dr Krishna Prasad Dr Anand Mishra Gleneagles Global Hospital Grant Medical Foundation, Ruby Hall Clinic Healthcare Global Enterprises Limited Kasturba Medical College King George Medical College Dr K S Kirushna Kumar Meenakshi Mission Hospital & Research Centre (MMHRC) Dr Rakesh Neve Opposite Mahamarg bus stop, Mumbai Naka, Nashik , Maharashtra, India Nashik Room Number 5, Basement, Lakdi-ka-pul, Hyderabad , Telangana Hyderabad ANDHRA PRADESH Cancer Building, 3rd floor, OPD No 302, 40, Sassoon Road, Pune Pune #8, HCG Towers, Tower IV, 5th Floor, P.Kalinga Rao Road, Sampangi Ram Nagar, Bangalore Bangalore KARNATAKA 7th Floor, Kasturba Medical College Hospital, Dept of Medical Oncology, Attavar, Mangalore , Karnataka Dakshina Kannada KARNATAKA Dept. of Endocrine Surgery, 7th Floor, Shatabdi Phase II, Shah Mina Road, Chowk, Lucknow, UP Lucknow UTTAR PRADESH centre.com ravikumar1960@hotmai l.com minishjain009@gmail.c om radheshyam_n@yahoo. com Dr.krishnaprasad@hot mail.com mishra101@gmail.com Dept. of Radiation Oncology, Ground floor, Lake Area, Melur Road, drkskk@yahoo.com Madurai , Tamilnadu, India. Madurai TAMIL NADU P.D.E.A. S Ayurved Department of Rugnalaya & Sterling Oncology, Ground Multi Speciality Hospital Floor, OPD#109, Sector drrneve@gmail.com 27, Near Bhel Chowk, Pradhikaran Nigdi, Pune , Maharashtra, India. Pune Dr Shailesh Bondarde Shatabdi Suyojit City Centre, page 3 / 8

4 Details of Ethics Committee Dr Lokesh K N Dr Tanveer Maksud Dr Akila Balaraman Superspecialty Hospital Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik Nashik Sri Venkateshwara Hospital Unique Hospital Multispecialty & VGM Hospital and Institute of Gastroenterology Department of Oncology, 3rd floor, #86, Hosur Main Road, Madiwala, Bangalore , Karnataka, India. Bangalore KARNATAKA shaileshbondarde@yah oo.com svhospital1997@gmail. com Department of Oncology, Ground floor, OPD #2, Opp. Kiran tanveermaksud@gmail. Motor, Nr. Canal, Civil com Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat , Gujarat, India. Surat GUJARAT Dept. of Medical oncology, 4th Floor, Room no. 411, 2100, Trichy Road, Rajalakshmi Mills Stop, Singanallur, Coimbatore, Tamil Nadu Coimbatore TAMIL NADU kbakila@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apple Hospital Ethics Committee Central India Cancer Ethics Committee Ethics Committee Sterling Hospital Ethics Committee, Unique Hospital Multispecialty and HCG Central Ethics Committee Committee Gleneagles Global Hospitals Committee Meenakshi Mission Hospital & Research Centre Approved 22/04/2017 No Approved 26/05/2017 No Approved 14/04/2017 No Approved 27/10/2016 No Approved 27/02/2017 No Approved 15/04/2017 No Approved 27/10/2016 No Approved 02/03/2017 No Committee, BGS Global page 4 / 8

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Hospitals Approved 13/10/2016 No Committee, City Cancer Centre Committee, King George s Medical College Committee, Poona Medical Research Foundation Committee, VGM Hospital Manavata Clinical Ethics Committee Manipal University Ethics Committee, Kasturaba Medical College and Hospital, Mangalore Shatabdi Hospital Ethics Committee Sri Venkateshwara Hospital Ethics Committee Status Approved 28/04/2017 No Approved 24/02/2017 No Approved 02/06/2017 No Approved 12/04/2017 No Approved 07/06/2017 No Approved 09/06/2017 No Approved 27/10/2016 No Date Approved/Obtained 14/12/2016 Health Type Patients Condition Breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Type Details Intervention Comparator Agent Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial ABRAXANE for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg/vial Inclusion Criteria 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 Celgene Corporation, USA. 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 page 5 / 8

6 Exclusion Criteria Age From Age To Gender Details Details Year(s) Year(s) Female 1.Female patients, 18 to 65 years of age (both inclusive) at the time of screening and capable of giving written informed consent prior to receiving any study medication. 2.Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease 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 investigators opinion. 4.ECOG performance status of less than or equal to 2. 5.Acceptable hemopoeitic, renal and liver function. Bone marrow function ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm3 Hemoglobin more than or equal to 9.0 g/dl Renal function Serum Creatinine less than 1.5 times ULN Hepatic function AST and ALT less than or equal to 2.5 times ULN Alkaline phosphatase less than 2 times ULN Bilirubin less than or 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 comply/adhere to the protocol requirements. 8.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 getting pregnant during the study. 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 and until 30 days 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 > Grade 2 at baseline. page 6 / 8

7 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Not Applicable Open Label 5.Presence of any significant physical or organ abnormality or active opportunistic infection (i.e. mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis jiroveci) as determined by the Investigator. 6.Patients not completely recovered from any toxicities from previous chemo-, hormone-, immuno-, or radiotherapies less than or equal to Grade 1. 7.A positive HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse or breath alcohol test. 8.Difficulty in fasting or consuming standard meals. 9.Patients who are: pregnant breast feeding of childbearing potential without a negative pregnancy test at baseline had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery 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. 14.Any other condition, that in the investigator s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory 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 IP administration or has less than 5 washout periods from previous therapy. 16.Patients who have not recovered from the side effects of 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 reference product. Pre-dose sample (within 5 mins prior to dosing), post-dose blood samples - after start of intravenous infusion, will be collected at (5 min), (10 min), (20 min), (25 min), 0.50 (30 min), (35 min), (45 min), 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment (India) To monitor the adverse events and to ensure the safety of patients. Total Sample Size=46 Sample Size from India=46 N/A 01/02/2017 NA page 7 / 8

8 Powered by TCPDF ( PDF of Trial Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary No Date Specified Years=0 Months=9 Days=0 Not Applicable Open to Recruitment None yet 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. Treatments will be allocated to the patients as per the pre-defined randomization sequence (i.e., reference drug then test drug or test drug then reference drug). During the treatment phase, each patient will receive a total of 1 dose of the reference product and 1 dose of the test product. The reference or test products 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 days. During each treatment period, serial blood samples will be collected at pre-determined 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 page 8 / 8