| CTRI Number |
CTRI/2010/091/001344 [Registered on: 18/10/2010] |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A Clinical Trial to evaluate the Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension and Taxol in Metastatic Breast cancer patients. |
Scientific Title of Study
Modification(s)
|
An Open Label, Randomized, Multiple-Dose, Parallel Study to Evaluate Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension (Intas Pharmaceuticals Ltd.) and Taxol® (Paclitaxel Injection Concentrate, Bristol-Myers Squibb.) in Metastatic Breast Cancer Patients after failure of prior chemotherapy. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 113-10 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Rajesh C N |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Opp Gujarat High court, Gota Ahmadabad
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940204020 |
| Fax |
07940204022 |
| Email |
rajeshcn@lambda-cro.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Opp Gujarat High court, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940204020 |
| Fax |
07940202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Praveen Shetty |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd |
| Address |
Opp Gujarat High court, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940204020 |
| Fax |
07940202022 |
| Email |
praveenshetty@lambda-cro.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Intas Pharmaceuticals Ltd, 2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad - 380009, Gujarat, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
2nd Floor, Chinubhai Center, Ashram Road, Ahmedabad 380-009, Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satish Kamath |
Aasha Cancer Centre |
1st floor, Ajit Darshan, 3- Petrol Pump, Thane - 400602
Thane
MAHARASHTRA |
9324514265
satishvkamat@rediffmail.com |
| Dr Satish Sonawane |
Anandrishijee Hospital and Medical Research Centre |
Plot No. 124, Anandrishi Marg, Ahmednagar
Ahmadnagar
MAHARASHTRA |
9657123636
sable.anjali99@gmail.com |
| Dr Tanveer Maksud |
Bharat Cancer Hospital & Research Institute |
Opp. H.P. Petrol Pump, Surat Bardoli Road, Saroli Surat-395 010
Surat
GUJARAT |
9909918887
tanveermaksud@yahoo.com |
| Dr Vijaykumar |
C.S.M. Medical University |
Department of Surgical Oncology, C.S.M. Medical University UP, Lucknow - 226003
Lucknow
UTTAR PRADESH |
9935383666
dr.vkumar_2007@gmail.com |
| Dr Ajay Mehta |
Central India Cancer Research Institute |
11, Shankar Nagar, West High Court Road, Nagpur – 440010
Nagpur
MAHARASHTRA |
9823190192
ajayonco@hotmail.com |
| Dr Kalyan Mukherjee |
Chittaranjan National Cancer Institute |
37, S. P. Mukherjee Road,Kalighat P. O, Kolkata - 700026
Kolkata
WEST BENGAL |
9830115905
kkmukherjee44@hotmail.com |
| Dr Rajnish Nagarkar |
Curie Manavata Cancer Centre |
Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr S Krishnan |
Dr. Rai Memorial Medical Centre |
No. 562, Century Plaza, Anna Salai, Teynampet, Â Chennai - 600018
Chennai
TAMIL NADU |
9952933735
krishnan_dr@yahoo.com |
| Dr Anup Majumdar |
HCG Medisurge Hospital |
IPGMER and SSKM Hospital, 244, A. J. C. Bose Road, Kolkata – 700020
Kolkata
WEST BENGAL |
9830152485
anup.majumdar@gmail.com |
| Dr Durgaprasad |
Indo-American Cancer Insititute & Research Centre |
Road # 14, Banjara hills, Hyderabad – 500 034
Hyderabad
ANDHRA PRADESH |
9848212569
durgaoncodr@yahoo.co.in |
| Dr Suraj Pawar |
Kolhapur Cancer Centre |
1182/98, ‘E’ ward, Mali Colony, Takala, Kolhapur, 416008
Kolhapur
MAHARASHTRA |
9822014908
surajpawar2001@yahoo.com |
| Dr S P Shrivastav |
Life Research Centre |
401, Param Doctor House, Station to Lal Darwaja Road, Surat - 395 003
Surat
GUJARAT |
9824196710
crconcolrc@yahoo.com |
| Dr J K Singh |
Mahavir Cancer Sansthan |
Phulwari Sherif, Patna - 801505
Patna
BIHAR |
9431021001
drjksingh147@hotmail.com |
| Dr Rakesh Neve |
Nandadeep Multispeciality Hospital |
1195/1, F.C.Road, Shivajinagar, Pune - 411003
Pune
MAHARASHTRA |
9881143140
rakesh.neve@gmail.com |
| Dr C T Satheesh |
Sri Venkateshwala Hospital |
# 86, House Main Road, Madiwala, Bangalore 560 068
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Central india Clinical research Independeant Ethics Committee, Nagpur (Dr. Ajay Mehta) |
Approved |
| Clinical Ethics Forum, Mumbai (Dr. Satish Kamath) |
Approved |
| Ethics committee of Indi Americal Cancer Institute and Research centre, Hyderabad (Dr. Durgaprashad) |
Approved |
| Ethics committee of Mahavir cancer sansthan, Patna (Dr. J. K. Singh) |
Approved |
| Hydrabad central ethics committee, Hyderabad (Dr. C. T. Satheesh) |
Approved |
| Independent ethics committee office of research cell, Lucknow (Dr. Vijaykumar) |
Approved |
| Independent ethics committee, Ahmdebad (Dr. Tanveer Maksud) |
Approved |
| Independent ethics committee, Ahmedebad (Dr. S.P. Shrivastav) |
Approved |
| Independent ethics committee, Dhanashree hospital, Pune (Dr. Satish Sonawane) |
Approved |
| Institutional Ethics Committee of CNCI, Kolkata (Dr. Kalyan Mukherjee) |
Approved |
| Institutional Ethics Committee of IOPGMER, Kolkata (Dr. Anup Majumdar) |
Approved |
| Institutional Ethics Committee, Chennai (Dr. S. Krishnan) |
Approved |
| Kolhapur independenet Ethics committee, Kolhapur (Dr. Suraj Pawar) |
Approved |
| Manavta Clinical research Institute professional ethics committee, Nashik (Dr. Rajnish Nagarkar) |
Approved |
| Nandadeep hospitals independent ethics committee, Pune (Dr. Rakesh Neve) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
NPLS (Nanosomal Paclitaxel Lipid Suspension) Arm A |
175 mg/m2 intravenous Infusion for 3 hours (+30 minutes) every 3 weeks for a maximum of 6 cycles |
| Intervention |
NPLS (Nanosomal Paclitaxel Lipid Suspension) Arm B |
80 mg/m2 intravenous Infusion for 1 hours (+10 minutes) weekly for a maximum of 18 cycles |
| Comparator Agent |
Taxol® Arm C |
175mg/m2 intravenously every 3 weeks for a maximum of 6 cycles |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
The patient is willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures
Patient must have histopathologically /cytologically confirmed breast cancer
Patient must have metastatic breast cancer after failure of prior combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated
Patient with adequate bone marrow, renal and hepatic function |
|
| ExclusionCriteria |
| Details |
Patient who has a history of hypersensitivity reactions to drugs formulated with Cremophor EL.
Patient who was previously exposed to Taxane Injection
Patient who has taken more than 1 prior chemotherapy treatment/regimen for metastatic breast cancer
|
|
Method of Generating Random Sequence
Modification(s)
|
|
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare the Overall Response Rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and Taxol® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapy |
18 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product 2.To compare the Disease Control Rate (CR or PR or SD) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and Taxol® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapy |
18 weeks for Disease Control Rate (CR or PR or SD) and at each visit for safety analysis |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
20/10/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Nanosomal Paclitaxel Lipid Suspension (NPLS) is a proprietary formulation for Paclitaxel developed by Intas Pharmaceuticals Limited consisting of small (< 100 nm) uniformly sized particles. The primary rationale for developing Lipid Based formulation of Paclitaxel is to improve the drug's safety profile by eliminating Cremophor EL and ethanol from TAXOL® (Paclitaxel). In NPLS, Paclitaxel is formulated with a mixture of well characterized Generally Recognized as Safe products which appear to be better tolerated than Cremophor EL and ethanol. Thus, NPLS may be administered to patients without the need of premedication with corticosteroids and anti-allergic treatment This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Paclitaxel Lipid Suspension (Intas Pharmaceuticals Ltd.) as compared to Taxol® in Metastatic Breast Cancer Patients after failure of prior chemotherapy
Patients will be administered Paclitaxel Injection concentrate (Reference product) at dose of 175 mg/m2 every 3 weeks or Nanosomal Paclitaxel Lipid Suspension (Test product) at dose 80 mg/m2 every week or 175 mg/m2 every 3 weeks as per randomization schedule, by IV infusion.
1. ARM A: Drug NPLS -175 mg/m2 intravenous Infusion for 3 hours (+30 minutes) every 3 weeks for a maximum of 6 cycles.
2. ARM B: Drug NPLS -80 mg/m2 intravenous Infusion for 1 hours (+10 minutes) weekly for a maximum of 18 cycles.
3. ARM C: Drug Taxol -175 mg/m2 intravenous Infusion for 3 hours (+30 minutes) every 3 weeks for a maximum of 6 cycles.
Using RECIST (version 1.1) disease status and tumor response will be assessed after every 6 weeks of treatment. Patients will also be evaluated for safety of the study drugs. The data cut-off for analysis will be cycle 6 (in case of Arm A and C) and cycle 18 (in case of Arm B).
Primary Objective:To compare the overall response rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly and every-3-week regimen) and Taxol® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapy
Secondary Objectives :To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product
To compare the Disease Control Rate (CR or PR or SD) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly and every-3-week regimen) and Taxol® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapy.
Total 120 Patients will be enrolled from India. Approximately 10 investigational sites will participate in the study
|