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CTRI Number  CTRI/2018/08/015506 [Registered on: 28/08/2018] Trial Registered Prospectively
Last Modified On: 21/11/2018
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical study to assess the comparative blood concentration of two anti-cancer drugs (test and marketed Paclitaxel) in patients with breast cancer  
Scientific Title of Study   A Randomized, Open Label, Multi Center, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial manufactured by Teva Pharmachemie, The Netherlands, for Teva Pharmaceuticals USA, and Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound), 100 mg/vial manufactured by Abraxis BioScience LLC, USA for Celgene Corporation, USA in Patients with Metastatic Breast Cancer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT/PAC/1701 (ver.1.0) (India) dated 25-May-2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saravanan G 
Designation  Project Manager, Clinical Development 
Affiliation  Lotus Labs Pvt. Ltd. 
Address  Clinical Development Dept. Lotus Labs Pvt. Ltd., No. 07, Jasma Bhavan Road, Millers Tank Bed Area Vasanthanagar, Bangalore -560 052, India

Bangalore
KARNATAKA
560052
India 
Phone  080-42708203  
Fax  080-42708466  
Email  saravanan_g@lotuslabs.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shailendra Sachan 
Designation  Associate Director, Clinical Operations 
Affiliation  Watson Pharma Pvt. Ltd 
Address  10th Floor, D Wing, Tower II, Seawoods Grand Central, Plot No. R-1, Sector- 40, Seawoods Railway Station, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  022-6282-9767  
Fax    
Email  shailendra.sachan@actavis.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailendra Sachan 
Designation  Associate Director, Clinical Operations 
Affiliation  Watson Pharma Pvt. Ltd 
Address  10th Floor, D Wing, Tower II, Seawoods Grand Central, Plot No. R-1, Sector- 40, Seawoods Railway Station, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  022-6282-9767  
Fax    
Email  shailendra.sachan@actavis.com  
 
Source of Monetary or Material Support  
Teva Pharmaceuticals, USA 
 
Primary Sponsor  
Name  Teva Pharmaceuticals USA 
Address  400 Interpace Parkway, Parsippany, NJ 07054, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jayanti Patel  Apple Hospital  Department of Oncology OPD, 1st floor, Udhna Darwaja, Ring Road, Surat, 395002, Gujarat, India
Surat
GUJARAT 		 9825121347

pateldrjayanti@gmail.com 
Dr Basavraj Kadalage  Aster Adher Hospital (Prerarna Hospital)  R S no 628, Ground Floor OPD no. 102 .B Ward Near Shastri Nagar ,Kolhapur 416012. Maharashtra
Kolhapur
MAHARASHTRA 		 9920448800

drbasavraj.aacr@gmail.com 
Dr Rajnish Vasant Nagarkar  Curie Manavata Cancer Centre  Opp Mahamarg Busstand,Mumbai Naka,Nashik-422004,Maharashtra,India
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercenter.com 
DrKirushna Kumar Kosanam Subramanian  Department of Oncology, Meenakshi Mission Hospital & Research Centre  Lake Area, Melur Road,Madurai-625107,Tamilnadu,India
Madurai
TAMIL NADU 		 9842113003

drkskk@yahoo.com 
Dr K Velavan   Erode Cancer Centre  Department of Clinical Research, Ground Floor New Building, Room No 7, 1/393, Velava Nagar, Perundhari Road , Thindal, Erode 638012, Tamil Nadu, India
Erode
TAMIL NADU 		 9842334222

kvels@rediffmail.com 
Dr M Gopichand  HCG City Cancer Centre  33-25-33,CH Venkata krishnayaa street,Suryarao pet,Vijayawada-520002,Andhra Pradesh,India
Krishna
ANDHRA PRADESH 		 9885260759

mgopichand@yahoo.com 
Dr G Raja  Hindu Mission Hospital  Department of Clinical Research, 1st Floor, Room No 101, 103, GST Road, NH 45, West Tambaram, Chennai 600045, Tamil Nadu, India
Chennai
TAMIL NADU 		 9841107677

rajaresearch17@gmail.com 
Dr Kartikeya Jain  Kailash Cancer Hospital and Research Center   Kailash Cancer Hospital and Research Center Muni Seva Ashram, Goraj-391760. Waghodia, Vadodara, Gujarat, India
Vadodara
GUJARAT 		 9427432642

kartikeya.jain@greenashram.org 
Dr Mahesh Kalloli  KLES Dr.Prabhakra Kore Hospital& MRC  KLES Dr.Prabhakra Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA 		 9945014996

mahesh.kalloli@gmail.com 
Dr Suraj Pawar  Kolhapur Cancer Pvt ltd  OPD No 1, R. S. 238 opp. Mayur Petrol Pump, near Orange Dhaba, Gokul Shirgaon Kolhapur 416234, Maharashtra
Kolhapur
MAHARASHTRA 		 9822014908

surajpawar2001@yahoo.co.in 
Dr Murali Krishna  Mahatma Gandhi Cancer Hospital & Research Institute  1/7, M V P Colony, Vishakapatnam- 530017, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 9848191287

muralivoona@yahoo.com 
Dr PN Sathiya Moorthy  Noble Hospital  No.4, Audiappa Street, Purasaiwakkam, Chennai-600084, Tamil Nadu, India
Chennai
TAMIL NADU 		 9444221535

sathiyamoorthypn@gmail.com 
Dr Vijay kumar Mahobia  Radiation and Oncology Department  Department of radiation Oncology,Government Medical College and Hospital,Nagpur-44000,Maharashtra
Nagpur
MAHARASHTRA 		 9881287465

drvijay_mahobia@yahoo.com 
Dr Tushar Patil  Sahyadri Speciality Hospital   Sahyadri Speciality Hospital, 30 C, Erandwane, Karve Road, Pune - 411004
Pune
MAHARASHTRA 		 9552522556

tussipats@hotmail.com 
Dr Aniket Thoke  Sanjeevani CBCC USA Cancer Hospital  Departments of Clinical Oncology , 1st Floor , Room No 204, In front of Jain Mandir, Dawada Colony, Pachpedi Naka, Raipur, Chhattisgarh -492001
Raipur
CHHATTISGARH 		 9752929741

drthoke@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospital & Critical Care (P) Ltd  Sahid Nagar Bhubaneshwar- 751007, Odisha, India
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
Dr CT Satheesh  Sri Venkateshwara Hospital  Department of Clinical Trials, 3rd Floor, No. 86, madiwala, hosur Main Road, Bangalore – 560068, India
Bangalore
KARNATAKA 		 9242698750

svhospital1997@gmail.com 
DrPradeep Kumar K N  Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd  No36, 01st Main Road,1st A main,5th cross, Nethravathi street, Maruthi Nagar, Nagarbhavi Main Road, Bangalore-560072
Bangalore
KARNATAKA 		 9738284545

pradeepkrn99@gmail.com 
Dr Rajender Singh Arora  Sujan Surgical Cancer Hospital and Amaravati Cancer Foundation  Department of Clinical trial 52/B, Shankar Nagar Main road, Amravati- 444606, Maharastra, India 
Amravati
MAHARASHTRA 		 9823097573

dr_rsarora@rediffmail.com 
Dr Tanveer Maksud  Unique multispeciality Hospital  Unique multispeciality Hospital, Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002 GUJARAT
Surat
GUJARAT 		 9909918887

tanveermaksud@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Amravati Ethics Committee, Sujan Surgical Cancer Hospital and Amaravati Cancer Foundation, 52/B, Shankar Nagar Main road, Amravati- 444606, Maharastra  Approved 
Ethics Committee, Apple Hospital, Udhna Darwaja, Ring Road, Surat, 395002, Gujarat  Approved 
Ethics Committee, Aster Adher Hospital, R S no 628, .B Ward Near Shastri Nagar ,Kolhapur 416012  Approved 
Ethics Committee, Kolhapur Cancer Centre, R. S. 238. Gokul Shirgaon, Karveer Kolhapur 416234, Maharashtra  Approved 
Ethics Committee, Sanjeevani Cancer Hospital, In front of Jain Mandir, Dawada Colony, Pachpedi Naka, Raipur, Chhattisgarh -492001  Approved 
Ethics Committee, Sri Venkateshwara Hospital, No. 86, madiwala, hosur Main Road, Bangalore – 560068  Approved 
Ethics Committee, Unique Multispeciality Hospital & Research Institute, Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002 Gujarat  Approved 
Institutional Ethics Committee, Erode Cancer Centre, 1/393, Velavan Nagar, Perundhari Road , Thindal, Erode 638012, Tamil Nadu  Approved 
Institutional Ethics Committee, HCG Curie City Cancer Centre,44-1-1/3,Padvalarevu,Machavaram,Vijayawada-520004,Andhrapradesh,India  Approved 
Institutional Ethics Committee, Hindu Mission Hospital, 103, GST Road, West Tambaram, Chennai 600045, Tamil Nadu  Approved 
Institutional Ethics Committee, Kailash Cancer Hospital and Research Center Muni Seva Ashram, Goraj-391760. Waghodia, Vadodara, Gujarat  Approved 
Institutional Ethics Committee, Mahatma Gandhi Cancer Hospital & Research Institute, 1/7, M V P Colony, Vishakapatnam- 530017, Andhra Pradesh  Approved 
Institutional Ethics Committee, Meenakshi Mission Hospital & Research Centre,Lake Area, Melur Road,Madurai-625107,Tamilnadu,India  Approved 
Institutional Ethics Committee, Noble Hospital, Room No: 701, No.4, Audiappa Street, Purasaiwakkam, Chennai-600084, Tamil Nadu  Approved 
Institutional Ethics Committee, Sparsh Hospital, A-407, Shaheednagar, Bhubaneshwar- 751007  Approved 
Institutional Ethics Committee,Department of Pharmacology,Government Medical College & Hospital, Nagpur-44000,Maharashtra  Approved 
Institutional Ethics Committee,KAHER,Nehru Nagar,JNMC,Belagavi-590010  Approved 
Manavata Clinical Research Institute Ethics Committee (MCRI EC), Curie Manavata Cancer Centre, Opp Mahamarg Busstand,Mumbai Naka,Nashik-422004,Maharashtra  Approved 
Sahyadri Hospitals Ltd. Ethics Committee, Sahyadri Clinical Research & Development Centre, 33/34 B, Makarand Bhave Path, Karve Road, Pune 411004, Maharashtra  Approved 
SCCMH-IEC, No36, 01st Main Road,1st A main,5th cross, Nethravathi street, Maruthi Nagar, Nagarbhavi Main Road, Bangalore-560072  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abraxane® for Injectable Suspension (paclitaxel proteinbound particles for injectable suspension)(albuminbound), 100 mg/vial  During each of the study periods, patients will receive a single dose (260 mg/m2), administered by intravenous infusion over 30±5 minutes. Calculated Body surface Area (BSA) will be used to determine a patient’s dose. 
Intervention  Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial  During each of the study periods, patients will receive a single dose (260 mg/m2), administered by intravenous infusion over 30±5 minutes. Calculated Body surface Area (BSA) will be used to determine a patient’s dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Female patient aged between 18 and 60 years of age (both inclusive).
2. Patient with confirmed (histological or cytological) diagnosis of metastatic (NO known CNS metastasis)
breast cancer or relapse within 6 months of adjuvant chemotherapy that included anthracycline unless clinically contraindicated.
3. Life expectancy of more than 6 months as judged by the Investigator.
4. ECOG PS (Eastern Cooperative Oncology Group performance status) of 0, 1 or 2.
5. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a
secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide,absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 30 days prior to study drug administration,
during study and 30 days after the last dose of study drug.
6. Patient able to understand, willing and likely to comply with study procedures and restrictions.
7. Patient has provided signed and dated Informed consent before initiating any study-related procedures. 
 
ExclusionCriteria 
Details  1. History or presence of significant coexisting disease or surgery (within 4 weeks prior to start of therapy) that could affect the action or disposition of the investigational product, or clinical or laboratory assessments.
2. Patients requiring any concurrent chemotherapy, hormonal therapy, immunotherapy, therapy with biologicals
or radiotherapy for the disease (any previous aforementioned treatments within 4 weeks of period 1 dosing).
3. Patients with medical conditions that preclude administration of chemotherapy [uncontrolled inter-current illness like unstable angina, myocardial infarction (within 6 months prior to study entry), congestive heart failure, serious cardiac arrhythmias, uncontrolled diabetes, autoimmune disease, or any uncontrolled systemic disease (e.g. recurrent pleural effusion / ascites, active infections, patients with immune deficiency disorders) or patients already on immunosuppressive drugs] or any other significant co-morbid conditions as determined
by the investigator(s).
4. Clinical significant abnormal laboratory values.
Bone marrow Function WBC greater than 3000/ microL
Absolute Neutrophil Count less than 1500/ microL
Platelet count less than 100,000/ microL
Haemoglobin less than 9.0 g/dl
Renal Function Serum Creatinine greater than 1.5 times ULN
Hepatic Function AST greater than 2.5 times ULN
ALT greater than 2.5 times ULN
Alkaline Phosphatase greater than 2.5 times ULN
Serum Albumin less than 3.0 gm/dL
5. Left ventricular ejection fraction (LVEF) of less than 50% as determined by Echocardiography (ECHO). History or presence of QTc prolongation (QTc greater than or equal to 470 ms, based on bazett’s correction method), left bundle branch block (LBBB), significant atrioventricular block (AV block) or any other significant cardiac disease.
6. Current (within 2 weeks of period 1 dosing) or regular use of any medication (including over the counter [OTC], herbal or homeopathic preparations) that could affect the action, absorption or disposition of the
investigational product, or clinical or laboratory assessment.
7. Positive result of urine screen for drugs of abuse (i.e., Amphetamines, Morphine, Benzodiazepines,Marijuana (THC), Cocaine and Barbiturates).
8. Patients with positive HIV, HBV, HCV and/or VDRL.
9. Known or suspected intolerance or hypersensitivity to Paclitaxel or any of the excipients or any other taxane.
10. Patients who have participated in any other clinical study in the preceding 30 days prior to the start of the study.
11. Patients who are pregnant or demonstrating a positive pregnancy screen or are currently breast-feeding or planning to become pregnant during study period.
12. Patients who have taken medication that are either substrates or inhibitor/inducer of CYP3A4/CYP2C8 enzyme less than 4 weeks prior to start of IMP or require as concomitant medication.
13. Patients with pre-existing sensory neuropathy of a severity greater than or equal to 3 grade as defined in National Cancer Institute Common Toxicity Criteria (CTC). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate the
bioequivalence between Test
product (Albumin bound
Paclitaxel) and Reference
product (ABRAXANE®) in
patients with Metastatic
Breast Cancer 		 PK Sampling- Day 1 to Day 4 of period-I & period-II of the study. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor safety.
To determine other
pharmacokinetic data. 		 Randomization (prior to period-I)- Day 0 upto End of Study- Day 14 of period-II 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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   N/A 
Date of First Enrollment (India)   15/09/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The purpose of the proposed study is to assess the bioequivalence of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial manufactured by Teva Pharmachemie, The Netherlands, for Teva Pharmaceuticals USA and Abraxane® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albuminbound), 100 mg/vial manufactured by Abraxis BioScience LLC, USA for Celgene Corporation, USA in patients with metastatic breast cancer.

The objectives of this proposed trial are as below:

To demonstrate the bioequivalence between Test product (Albumin bound Paclitaxel) and Reference product (ABRAXANE®) in patients with Metastatic Breast Cancer.
To monitor safety
To determine other pharmacokinetic data

A total of 66 patients will be randomized in the study to establish bioequivalence

Analytical Method:
Unbound and total paclitaxel concentration in plasma will be measured using a validated bio-analytical method and according to the bio-analytical laboratory’s standard operating procedures and applicable regulatory
principles. Unbound paclitaxel concentration in plasma will be measured till 24 hours and total paclitaxel up to 72 hours after start of infusion.
Due to the sensitivity of Paclitaxel to ultraviolet (UV) light, the blood sample collection, sample transfer, sample separation, sample segregation and sample processing procedure will be done under yellow monochromatic light.
Sample collection, processing details and storage of plasma samples at study site will be provided in procedure manual for sample collection.

 
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