| CTRI Number |
CTRI/2015/07/006062 [Registered on: 31/07/2015] Trial Registered Prospectively |
| Last Modified On: |
21/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the Effectiveness and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension in comparison with Taxol in Breast cancer patients. |
|
Scientific Title of Study
|
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 |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 113 -10, Ver. No- 02, Date- 12 Dec 2014 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Amol Dongre |
| Designation |
Project Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202562 |
| Fax |
07940202021 |
| Email |
amoldongre@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Plot No. 32, Near Silver Oak Club, S. G. Highway
Ahmadabad
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Ranpura |
| Designation |
Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Plot No. 32, Near Silver Oak Club, S. G. Highway
GUJARAT
380061
India |
| Phone |
07940202074 |
| Fax |
07940202021 |
| Email |
ankitranpura@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd, 2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
2nd Floor, Chinubhai Centre, Ashram Road, Ahmedabad 380-009, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Koushik Chatterjee |
B.P Poddar Hospital & Medical Research Ltd. |
Department of Radiology, Room No: 1, 71/1, Humayun Kabir Sarani, Block-G, New Alipore- 700053
Kolkata
WEST BENGAL |
9432387321
drkoushik.chatterjee@gmail.com |
| Dr Rakesh Taran |
CHL CBCC Hospital |
Convenient Hospital Ltd, CHL-Hospital & CHL-CBCC Cancer Center, Unit of CHL Group of Hospitals, Department of Oncology, Near L.I.G. Square, A.B. Road Indore - 452008
Indore
MADHYA PRADESH |
9009779517
rakeshtaran@yahoo.com |
| Dr M Vikranth |
City Cancer Hospital |
City Cancer Center, 33 - 25 - 33, Ch.Venkata Krishnayya street, suryarao pet, Vijayawada - 520002
Krishna
ANDHRA PRADESH |
8662430871
mvikranth@gmail.com |
| Dr Ravi kumar Saxena |
Global Hospitals |
Department of Oncology, 6-1-1070/1 to 4, Lakdikapool- 500004
Hyderabad
ANDHRA PRADESH |
9849385000
ravikumar1960@hotmail.com |
| Dr Bhavin A Shah |
Hemato Oncoloty Clinic Ahmedabad Pvt. Ltd. |
Department of Oncology, Room No. 3, 1st Floor, Vedanta Institute of Medical Science, Near Samved Hospital, Stadium commerce college road, Navrangpura - 380009
Ahmadabad
GUJARAT |
9824047561
research@hematooncologyclinic.com |
| Dr Anupama Mane |
Jehangir Clinical Development Centre Pvt. Ltd. |
Department of Radiotherapy, Room No. 9, Jehangir Hospital Premises, 32 Sassoon Road - 411001
Pune
MAHARASHTRA |
9850997536
anupama.mane@gmail.com |
| Dr Mahesh V Pawar |
KEM Hospital Research Centre |
Department of Oncology, Room No. 2, 3rd Floor, Day Care Centre, Banoo Koyaji Building, Rasta Peth, Sardar Moodliar Road - 411011
Pune
MAHARASHTRA |
9823133390
drmaheshoncosurg@gmail.com |
| DrPragnya Coca |
Narayana Health Hospitals |
Department of Radiology, 258/A Bommasandra Industrial Area, Anekal Taluk, Hosur Road- 560099
Bangalore
KARNATAKA |
8027835315
pragnya.coca.dr@nhhospitals.org |
| Dr Ajay Sharma |
Rajiv Gandhi Cancer Institute and Research Centre |
Department of Radiotherapy, Room No. 6, Sector 5, Near West Rohini Metro Station, Rohini- 110085
New Delhi
DELHI |
01147022441
ajaysharma04@rediff.com |
| Dr Chaitanyanand B Koppiker |
Ruby Hall Clinic Wanowarie |
Department of Radiotherapy, 59/6, Wano, Kedari Nagar Rd, Disney Park, Azad Nagar Wanowarie- 411040
Pune
MAHARASHTRA |
9822674040
koppiker@gmail.com |
| Dr Sanjay B Ahire |
Shatabdi Super Specialty Hospital |
Department of Radiology, Room No. 5, Suyojit City Centre, Opposite Mahamarg Bus Stand, Mumbai Naka - 422005
Nashik
MAHARASHTRA |
9822012427
dr.sba@rediffmail.com |
| Dr T M Suresh |
Srinivasam Cancer Care Hospitals India Pvt. Ltd |
Department of Oncology, No. 236/1, Vijayashree Layout, Arekere, Bannerghatta Main Road- 560076
Bangalore
KARNATAKA |
9901917427
sureshtm.1955@yahoo.com |
| Dr Nikunj K Vithalani |
Unique Hospital - Multispecialty & Research Institute |
Department of Oncology,Room No. 4, Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta - Sosyo Circle Lane, Off Ring Road - 395002
Surat
GUJARAT |
9909918887
drnikunjvithalani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd.,Dr. Anupama Mane |
Approved |
| Ethics Committee of Care Institute of Medical Sciences, Dr. Bhavin A Shah |
Approved |
| Ethics Committee of KEM Hospital Research Centre,Dr. Mahesh V Pawar |
Approved |
| Ethics Committee, B.P Poddar Hospital & Medical Research Ltd.,Dr. Koushik Chatterjee |
Approved |
| Ethics Committee, Shatabdi Super Specialty Hospital, Dr. Sanjay B Ahire |
Approved |
| Ethics Committee, Unique Hospital - Multispecialty & Research Institute,Dr. Nikunj K. Vithalani |
Approved |
| Instititional Review Board, Rajiv Gandhi Cancer Institute and Research Centre,Dr. Ajay Sharma |
Approved |
| Institutional Ethics Committee,City Cancer Centre, Dr M Vikrant |
Approved |
| Institutional Ethics Committee,Dr Ravi kumar Saxena |
Approved |
| Institutional Ethics Committee,Dr. Chaitanyanand Koppiker |
Approved |
| Institutional Ethics Committee,Dr. T M Suresh |
Approved |
| Integrity Ethics Committee, CHL Hospitals, Dr. Rakesh Taran |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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
|
| Type |
Name |
Details |
| Intervention |
Nanosomal Paclitaxel Lipid Suspension for Injection 1 mg/ mL |
Dose:175 mg/m2,Frequency:Every 3 weeks,Mode of Administration:IV,Duration of treatment:4 Months |
| Comparator Agent |
Taxol® (Paclitaxel) Injection Concentrate, 6 mg/ mL |
Dose:175 mg/m2,Frequency:Every 3 weeks,Mode of Administration:IV,Duration of treatment:4 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. The patient willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures
2. Patient must have histopathologically /cytologically confirmed breast cancer
3. Have at least one measurable lesion as per the RECIST criteria (Version 1.1)
4. Patients with life expectancy of at least 6 months.
5. Patient must have negative serum pregnancy test at screening |
|
| ExclusionCriteria |
| Details |
1. Patient who has already exposed to Taxane Injection
2. Any of the following cardiac conditions:
• Unstable angina
• Myocardial infarction within the past 6 months
• Severe uncontrolled ventricular arrhythmias
• Clinically significant pericardial disease
• Electrocardiographic evidence of acute ischemia or active conduction system abnormality
• History of cardiac disease that met the NYHA Classification class 2 or greater
3. Known history of drug addiction within last 1 year
4. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Best overall response rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension and Taxol® in patients with metastatic breast cancer. |
To end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product.
2. To compare the Disease Control Rate. |
To end of the study. |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/08/2015 |
| 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
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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 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 2. ARM C: Drug Taxol -175 mg/m2 intravenous infusion for 3 hours (+30 minutes) every 3 weeks
Using RECIST criteria (version 1.1), disease status and tumor response will be assessed after every 6 weeks of treatment. Subsequent cycles will follow institutional standards. Patients will also be evaluated for safety of the study drugs. |