FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/04/004528 [Registered on: 07/04/2014] Trial Registered Prospectively
Last Modified On: 05/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Randomized, Open Label,Two Period, Single Dose Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Patients with Breast Cancer 
Scientific Title of Study   A Randomized, Open Label, Two Period, Single Dose, Two Way Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Patients with Locally Recurrent or Metastatic Breast Cancer 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CLR_12_10 Version 01 Amendment 02 dated 20 May 2015  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 Reserach Company Ltd. 
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  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 Reserach Company Ltd. 
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  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 Reserach Company Ltd. 
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  912266455685  
Email  clinical.trials@sparcmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Advanced Research Company Ltd, 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India 
 
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 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 = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satya Suresh Attili  "BIBI General Hospital and Cancer Centre,   16-3-991/1/C, Govt. Printing Press Road, Malakpet Hyderabad- 500 024 (India)."
Hyderabad
ANDHRA PRADESH 		 040-24528122

sureshattili@yahoo.com 
Dr K Pavithran  Amrita Institute of Medical Sciences (AIMS),   Department of Medical Oncology, Room no 2, Ground Floor, Block A, Tower 3, Ernakulam, Cochin - 682041, Kerala, India
Ernakulam
KERALA 		 0484-4003003

pavithrank@aims.amrita.edu 
Dr Ajay Mehta  Central India Cancer Research Institute  West High Court Road, Shankar Nagar, Nagpur 440010, Maharashtra
Nagpur
MAHARASHTRA 		 0712-2520956

ajayonco@hotmail.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital & Research Centre  Room No.8, Annex Building, Near Mhatre Bridge, Erandawane, Pune 411004
Pune
MAHARASHTRA 		 02066023000
02066023025
drchetandeshmukh@rediffmail.com 
Dr V Srinivasan  Dr.Kamakshi Memorial Hospital  No 1, Radial Road, Palikaranai, Chennai 600100, Tamil Nadu
Chennai
TAMIL NADU 		 044-22469200

vsrinivasan09@gmail.com 
Dr Niraj Bhatt  Kailash Cancer Hospital and Research Center  Chamber - 2, Chemotherapy ward, Muni Seva Ashram, Goraj-391760, Tal. Vaghodia, Dist. Vadodara, Gujarat
Vadodara
GUJARAT 		 02668268040
02668268048
nirajbhatt1974@gmail.com 
Dr Minish Jain  KEM Hospital Research Centre  3 rd floor, Day Care,Bhanu Koyaji Building, Sardar Moorliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 		 02066037336
02026125603
drminishjain@yahoo.in 
Dr Kirushna Kumar  Meenakshi Mission Hospital and Research Centre,  Department of Oncology, OPD ground floor, Lake Area, Melur Road, Madurai 625107,Tamil Nadu
Madurai
TAMIL NADU 		 0452-2588741

drkskk@yahoo.com 
Dr Rama Krishna  MNJ Institute of Oncology and Regional Cancer Center,   Clinical Research Department, 3rd floor, Room no 10, Red Hills, Lakadika Pul, Hyderabad 500004
Hyderabad
ANDHRA PRADESH 		 40-23318414

rkmalladi@yahoo.com 
Dr Shailesh Bondarde  Shatabdi Super Specialty Hospital  1st Floor, G-11, Suyojit City Centre, Opp Mahamarg Bus Stand, Mumbai Naka, Nashik 422005.
Nashik
MAHARASHTRA 		 02532501888
02532501999
shaileshbondarde@yahoo.com 
Dr Shyam Aggarwal  Sir Ganga Ram Hospital  Room No 1219, Department of Medical Oncology,Rajinder Nagar, New Delhi 110060
New Delhi
DELHI 		 9811075870

drshyam_aggarwal@yahoo.com 
Dr Jyoti Bajpai  Tata Memorial Hospital,  Dr E Borges Road, Parel, Mumbai 400012,Maharashtra
Mumbai
MAHARASHTRA 		 022-24177287

dr_jyotibajpai@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
BIBI Institutional Ethics Committee  Submittted/Under Review 
Central India Cancer Research Institutional Ethics committee  Approved 
Ethics Committee of KEM Hospital Research Centre  Approved 
Ethics committee-Sir Gangaram Hospital  Submittted/Under Review 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre  Approved 
Institutional Ethics Committee, Meenakshi Mission Hospital & Research Centre  Approved 
Institutional Ethics Committee,Amrita Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee,Dr. Kamakshi Memorial Hospital  Approved 
Institutional Ethics Committee,Kailash Cancer Hospital & Medical Centre  Approved 
Institutional Ethics Committee,Tata Memorial Hospital  Approved 
MNJ Institutional Ethics Commiittee  Submittted/Under Review 
Shatabdi Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Notified 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option, (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abraxane®  Abraxane® will be infused i.v. over 30-minutes. The treatment period consist of 3-week treatment cycles (2 cycles) 
Intervention  Paclitaxel Injection Concentrate for Nano-dispersion (PICN)  PICN will be infused i.v. over 30-minutes. The treatment period consist of 3-week treatment cycles (2 cycles) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  -The subject has given written informed consent.
-Histologically or cytologically confirmed diagnosis of breast cancer;
-Locally recurrent or metastatic breast cancer; Age 18 to 65 years, inclusive;
-ECOG Performance Status less than or eual to 1;  
 
ExclusionCriteria 
Details  -Known hypersensitivity to both the study drugs or their excipients;
-Presence of clinically symptomatic active CNS metastases;
-Pre-existing clinically significant peripheral neuropathy;
-Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pharmacokinetic (PK) profiles of PICN and Abraxane  Pharmacokinetic (PK) samples will be collected on Day 1 & 2 of Cycle 1 & 2 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of PICN and Abraxane  Safety information will be collected during subject visits on Day 1, 8, 15 of Cycle 1 & 2 and end-of-study. 
 
Target Sample Size
Modification(s)  		 Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   18/05/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a bioavailability study.  In this study, PICN and Abraxane® will be administered to enrolled subjects in either period 1 (cycle 1) or period 2 (cycle 2).  In cycle 1, subjects will be randomized to receive an intravenous (IV) infusion of either PICN or Abraxane®, over 30 minutes, according to the randomization schedule generated using SAS® software or by using www.randomization.com.  Treatment in cycle 2 will be crossed over. During each of cycle, PK samples will be collected.  End of study visit will be conducted on Day 22 of cycle 2. 
Close