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CTRI Number  CTRI/2016/06/007043 [Registered on: 28/06/2016] Trial Registered Prospectively
Last Modified On: 05/07/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical research study of SPARC1612 in breast cancer 
Scientific Title of Study   A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of SPARC1612 and reference1612 in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CLR_16_12 version 01 Amendment 00 dated 6 Apr 2016  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 Ltd 
Address  Sun Pharma Advanced Research Company Ltd, 17/B,Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax  912266455685  
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 Ltd 
Address  Sun Pharma Advanced Research Company Ltd, 17/B,Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  912266455645  
Fax  912266455685  
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 Ltd 
Address  Sun Pharma Advanced Research Company Ltd, 17/B,Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai

Mumbai
MAHARASHTRA
400093
India 
Phone  02266455645  
Fax  912266455685  
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 Ltd 
Address  Sun Pharma Advanced Research Company Ltd, 17/B,Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai,Maharashtra 400093 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrShyamal Kumar Sarkar  Medical College and Hospital   88, college street, radiotherapy department opposite: OPD building
Kolkata
WEST BENGAL 		 9831097315

shyamalsarkar20141@gmail.com 
Dr Sushil Meshram  Dept. of Radiation Therapy and Oncology, Govt. Medical College and Hospital  Department of Radiation Therapy and Oncology, Govt. Medical College and Hospital, Nagpur 440003 Maharashtra, India"
Nagpur
MAHARASHTRA 		 7028966535

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

radheshyam_n@yahoo.com 
Dr Kakali Choudhury  Health Point Hospital  21 Prannath Pandit Street (Opposite Lansdowne West Bengal, India Padmapukur)
Kolkata
WEST BENGAL 		 8420011311

mailkakalichoudhury@gmail.com 
Dr Bidisha Ghosh Naskar  Institute of post graduate medical education and research  244 AlC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 		 9432164842

bghoshn@gmail.com 
Dr Sonia Tiwari  Jeevan Jyoti Hospital & Research Centre  162, Bai ka bagh, Lowther Road, Allahabad-211003, U.P., India
Allahabad
UTTAR PRADESH 		 9450629141

tiwarisonia05@gmail.com 
Dr Jyothi N  Karnataka Cancer Hospital & Research Centre  99 J B Kaval, Krishananda Nagar, Nandini Layout
Bangalore
KARNATAKA 		 9448051964

jyothichinnali@yahoo.com 
Dr Krishna Prasad  Kasturba Medical College  Department of Medical Oncology,Attavar, Mangalore -
Dakshina Kannada
KARNATAKA 		 9880345666

drkrishnaprasad@hotmail.com 
DrAnand Kumar Mishra  King Georges Medical University   Department of General Surgery, Uttar Pradesh,Chowk, Lucknow-226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 9415007391

mishra101@gmail.com 
Dr Amod Yadav  Lifepoint multispecialty hospital Pvt Ltd.   145/1, Mumbai-Banglore Highway, Near Hotel Sayaji, Wakad
Pune
MAHARASHTRA 		 9890196118

dramod@yahoo.com 
DrKaiumarz Sohrab Sethna  Lokmanya Tilak Munciple Medical College and General Hospital  College Building, 1st floor, Room No. 21, Sion
Mumbai
MAHARASHTRA 		 9820882603

kssethna@yahoo.com 
Dr Kirushna Kumar  Meenakshi Mission Hospital and Rearch Centre  Lake Area, Melur Road-625107 Madurai
Madurai
TAMIL NADU 		 9787713004

drkskk@yahoo.com 
Dr Tushar Patil  Sahyadri Clinical Research and Developmeot Cente  33/348, Makarnd Bhave Path, Karve Road
Pune
MAHARASHTRA 		 9552522556

tussipats@hotmail.com 
Dr Lokanath  Srinivasam Cancer Care Hospital Pvt Ltd  236/1, 2nd floor, Vijayshree layout, Arekere, Bannerghatta road
Bangalore
KARNATAKA 		 9845695589

drlok61@gmail.com 
Dr Jitendra Kumar Singh  SS Hospital and Research Centre  Doctors Colony, Malahi Pakri Chowk, Kankarbagh
Patna
BIHAR 		 9431021001

drjksingh147@hotmail.com 
Dr Yogesh Jain  Sujan Surgical Cancer Hospital and Amravati Cancer Foundation  52/B, Shankar Nagar, Main Road,
Amravati
MAHARASHTRA 		 9373569046

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

shravan74@yahoo.com 
Dr K B Akila  VGM Cancer Care Centre  Oncology Department, 4th floor, No. 2100, Trichy Road,(Rajalakshmi Mill stop)
Coimbatore
TAMIL NADU 		 9842270651

kbakila@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Amravati Ethics Committee  Approved 
Ethics Committee Kodlikeri Memorial Hospital and CIIGMA Hospital  Submittted/Under Review 
HCG-Central Ethics Committee  Approved 
Health Point Ethics Committee  Approved 
Institute Ethics Committee King Georges Medical University  Submittted/Under Review 
Institute Ethics Committee Srinivasam Cancer Care Hospital Pvt Ltd  Submittted/Under Review 
Institutional Ethics Committee - Human Research (IEC-HR)  Submittted/Under Review 
Institutional Ethics Committee For Human Research  Submittted/Under Review 
Institutional Ethics Committee SS Hospital and Research Centre  Submittted/Under Review 
Institutional ethics Committee VGM Hospital  Submittted/Under Review 
Institutional Ethics Committee_Allahabad  Approved 
Institutional Ethics Committee_Bangalore  Approved 
Institutional Ethics Committee_Madurai  Submittted/Under Review 
Institutional Ethics Committee_Nagpur  Submittted/Under Review 
IPGME&R Research Oversight Committee  Approved 
LPR ethics Ethics Committee  Approved 
Manipal University Ethics Committee  Approved 
Sahyadri Hospitals Limited Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, Metastatic breast cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abraxane  administered as 250mg/m2 for 30 minutes 
Intervention  PICN  administered as 250mg/m2 for 25 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  - The subject has given written, informed consent (or
legally acceptable representative /impartial
witness when applicable) and is available for the
duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer
- Locally recurrent or MBC for which taxane-based therapy is an appropriate
treatment option
- Male or female aged ≥ 18 years

 
 
ExclusionCriteria 
Details  - Presence of clinically symptomatic active CNS metastases
- Pre-existing clinically significant peripheral neuropathy
- Inability to undergo venipuncture and/or tolerate venous access
- Known hypersensitivity to either of the study drugs or their excipients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pharmacokinetic parameter: Cmax, AUC0-t and AUC0-∞

 		 up to 72 hours

 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events  51 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2016 
Date of Study Completion (India) 05/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This clinical study is designed to characterize PK parameters and potential BE for PICN and Abraxane and to evaluate safety of both formulations. 
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