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CTRI Number  CTRI/2016/12/007565 [Registered on: 13/12/2016] Trial Registered Prospectively
Last Modified On: 10/06/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Pharmacokinetic study of SPARC1613 and Reference1613 
Scientific Title of Study   A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC). 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CLR_16_13, version 01, amendment 04, 05 Sep 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Limited 
Address  Sun Pharma Advanced Research Company Ltd 17/B, Mahal Industrial Estate, Mahakali Caves Road Andheri East, Mumbai.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645   
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Limited 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Mudgal Kothekar MD 
Designation  Associate Vice President Clinical Development 
Affiliation  Sun Pharma Advanced Research Company Limited 
Address  17/B, Mahal Indudtries Limited, Mahakali Caves Road, Andheri East.

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax    
Email  Clinical.Trials@sparcmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Advanced Research Company Limited 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093. 
 
Primary Sponsor  
Name  Sun Pharma Advanced Research Company Limited 
Address  17/B,Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 24  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ghanshyam Patel  Apple Hospital  Udhna Darwaja Ring Road, 39500
Surat
GUJARAT 		 9376913131

gnonco@gmail.com 
Dr Aditya Adhav  Curie Manavata Cancer Centre  Opp. Mahamarg Bus Stand, Mumbai Naka, 422004, India.
Nashik
MAHARASHTRA 		 9860376209

draditya@mcrinasik.com 
Dr Sushil Meshram  Dept. of Radiation Therapy and Oncology, Govt. Medical College and Hospital  "Dept. of Radiation Therapy and Oncology, Govt. Medical College and Hospital"
Nagpur
MAHARASHTRA 		 8390409535

drkambleonco@gmail.com 
DrGRaja  Dr Rai Memorial Medical Centre  No 526, Century Plaza, Annasalai Teynampet, Near Canara Bank, 600018, India
Chennai
TAMIL NADU 		 9841107677

grajaro78@gmail.com 
Dr Manasi Shah  HCG Multi Speciliaty Ethic Committee  HCG Multispecialty Hospital & HCG Cancer Centre, Sola Science City Road, Near Sola Bridge, 380060
Ahmadabad
GUJARAT 		 7096012800

mansi1227@gmail.com 
Dr Radheshyam Naik  Health Care Global Enterprises Ltd.  HCG Towers, No. 8, P.Kalinga Rao Road, Sampangi Ram Nagar, 560027, India.
Bangalore
KARNATAKA 		 9731310682

radheshyam_n@yahoo.com 
Dr Guruprasad Mohanty  Kailash Cancer Hospital & Research Centre  Muni Seva Ashram, Goraj- 391760, Tal-Waghodia
Vadodara
GUJARAT 		 9909497459

drgpmohanty@hotmail.com 
Dr Sourjya Banerjee  Kasturba Medical College Hospital  Department of Radiotherapy and Oncology,Kasturba Medical College Hospital, Attavar, 575001
Dakshina Kannada
KARNATAKA 		 9880345339

sourjya.banerjee@gmail.com 
Dr Rohan Bhise  KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre  Nehrunagar, 590010, India
Belgaum
KARNATAKA 		 8312551355

rohanbhise30@gmail.com 
DrKaiumarz Sohrab Sethna  Lokmanya Tilak Munciple Medical College and General Hospital  Room no. 21, College building, Sion
Mumbai
MAHARASHTRA 		 9820882603

kssethna@yahoo.co.uk 
Dr Pradeep Shah  M S Patel Cancer Center  Shree Krishna Hospital,Gokal Nagar,Karamsad,380060
Anand
GUJARAT 		 9825040833

pradeeps@charutarhealth.org 
Dr Rakesh Reddy Boya  Mahatma Gandhi Cancer Hospital and Research Institute  1/7,MVP Colony, 530017, India
Visakhapatnam
ANDHRA PRADESH 		 9013355935

drrakshreddyboya@yahoo.com 
Dr Chandra Sekhar Tamane  Mahatma Gandhi Missions Medical College & Hospital  N-6 CIDCO, 431 003, INDIA
Aurangabad
MAHARASHTRA 		 9225316906

chandratamane@yahoo.com 
Dr Kirushna Kumar  Meenakshi Mission Hospital and Rearch Centre  Lake Area, Melur Road-625107
Madurai
TAMIL NADU 		 9842113003

drkskk@yahoo.com 
Dr Rakesh Neve  P.D.E.AS Ayurved Rugnalay & Sterling Multispeciality Hospital  "Sector 27, Near Bhel Chowk, Nigdi,Pradhikaran, 411 044, India"
Pune
MAHARASHTRA 		 9881143140

rakesh.neve@gmail.com 
Dr Tushar Patil  Sahyadri Clinical Research & Developmeot Cente  "A unit of Sahyadri Hospitals Limited, 33/348, Makarnd Bhave Path, Karve Road, 411004
Pune
MAHARASHTRA 		 9552522556

tussipats@hotmail.com 
Dr Sampath Kumar MN  Sapthagiri Institute of Medical Science & Research Centre  15, Chikkasandra, Hesaragatta Main Road, 560090
Bangalore
KARNATAKA 		 9108506581

sampathkumarmn02@gmail.com 
Dr Viraj Vijay Borgaonkar  Seth Nandlal Dhoot Hospital  A-1, MIDC, Chikalthana, Jalna Road, 431210.
Aurangabad
MAHARASHTRA 		 9225330004

viraj.oncosurg@outlook.com 
Dr Shailesh Bondarde  Shatabdi Super Speciality Hospital  Suyojit City Centre, Opposite to Mahamarg Bus stand, Mumbai Naka, 422005
Nashik
MAHARASHTRA 		 9822012427

shaileshbondarde1971@gmail.com 
Dr K C Lakshmaiah  Shrinivasam CAncer Care Multispeciality Hospitals India Pvt Ltd  #36,1st_A main,5th cross, 4th Floor, Nethravati Street, Maruthi Nagar, Nagar Bhavi Main Road, 560072, India
Bangalore
KARNATAKA 		 9448055949

kcluck@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospitals and Critical Care Pvt. Ltd./Dr. Ghanashyam Biswas  Plot No. A/407, Sahid Nagar, bhubaneswar 751007, Odisha, India
Khordha
ORISSA 		 9937500878

drgbiswas@yahoo.com 
Dr Somesh Chandra  Sterling Hospital  2nd floor, Sterling Hospital road, Memnagar, 380052, India.
Ahmadabad
GUJARAT 		 9426014627

somesh@sterlinghospitals.com 
Dr Tanveer Maksud  Unique Hospital Multispecialty and research institute  Opp Kiran Motor, near Canal, Civil hospital char Rasta- Sosyo Circle Lane, off Ring road, 395002, India.
Surat
GUJARAT 		 9909918887

tanveermaksud@gmail.com 
Dr Shravan Tungenwar  United CIIGMA Institute of Medical Sciences Pvt.Ltd.  Plot no.6, 7, Survey No.10, Shahnoorwadi, Darga Road,431 005, India
Aurangabad
MAHARASHTRA 		 9763708445

drshravan.uch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 24  
Name of Committee  Approval Status 
Apple Hospital Ethics Committee_Surat  Approved 
Dr Rai Memorial Medical Centre Institutional Ethics Committee  Approved 
Ethics Committee Kodlikeri Memorial Hospital and CIIGMA Hospital_Aurangabad  Approved 
Ethics Committee, Unique Hospital Multispeciality and Research Institute _Surat  Approved 
Ethics Committee_Belgaum  Approved 
HCG Multispecialty Ethics Committee_Ahmedabad  Approved 
HCG-Central Ethics Committee_Bangalore  Approved 
Institutional Ethics Committee - Human Research (IEC-HR)_Mumbai  Approved 
Institutional Ethics Committee Kailash Hospital and Research Centre_Vadodara  Approved 
Institutional Ethics Committee Sparsh Hospital_Bhubaneshwar  Approved 
Institutional Ethics committee_Bengaluru  Approved 
Institutional Ethics Committee_Karamsad  Approved 
Institutional Ethics Committee_Madurai  Approved 
Institutional Ethics Committee_Nagpur  Approved 
Mahatma Gandhi CAncer Hospital & Research Institute_Visakhapatnam  Approved 
Manavata Clinical Research Institute Ethics Committee (MCRI EC)_Nashik  Approved 
Manipal University Ethics Committee_Mangalore  Approved 
MGM Ethics committee for research on human subjects_Aurangabad  Approved 
Sahyadri Hospitals Limited Ethics Committee_Pune  Approved 
Sapthagiri Institute of Medical Science & Research Centre Institutional Ethics Committee_Bangalore  Approved 
Seth Nandlal Dhoot Hospital Institutional Ethics Committee_Aurangabad  Approved 
Shatabdi Hospitals Ethics Committee_Nashik  Approved 
Sterling Hospital Ethics Committee_Ahmedabad  Approved 
Sterling Hospital Institutional Ethics Committee_Pune  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Metastatic breast cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Reference1613  Intravenous infusion of 260 mg/m2 
Intervention  SPARC1613  Intravenous infusion of 260 mg/m2 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  91.00 Year(s)
Gender  Both 
Details  1. The subject has given written, informed consent (or legally acceptable representative /impartial
witness when applicable) and is available for the duration of study
2. Histologically or cytologically confirmed diagnosis of breast cancer
3. Estimated life expectancy of at least 12 weeks
4. ECOG performance status less than 1  
 
ExclusionCriteria 
Details  1. Known hypersensitivity to either of the study drugs or their excipients
2. Inability to undergo venipuncture and/or tolerate venous access
3. Presence of clinically symptomatic active CNS metastases, including leptomeningial
involvement, requiring steroid or radiation therapy
4. Pre-existing clinically significant peripheral neuropathy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pharmacokinetic parameter Cmax, and AUC  Pharmacokinetic parameter Cmax, and AUC 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size
Modification(s)  		 Total Sample Size="142"
Sample Size from India="142" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="142" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 29/07/2017 
Date of Study Completion (India) 04/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
This was a multicenter, open-label, randomized, two-period, two treatment, single dose, crossover
bioequivalence study.

 
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