| CTRI Number |
CTRI/2009/091/000795 [Registered on: 22/01/2010] |
| Last Modified On: |
15/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the safety and efficacy of Non-pegylated Liposomal Doxorubicin (Nudoxa) as compared to doxorubicin in patients with metastatic breast cancer. |
Scientific Title of Study
Modification(s)
|
A phase II/III Open label Multicentric Randomized trial to determine the safety and efficacy of Non-pegylated Liposomal Doxorubicin (Nudoxa) at two different dose levels as compared to doxorubicin in patients with metastatic breast cancer. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NPLD.08.003.01.1.PROT ,version 1.0 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr RHJani |
| Designation |
Senior Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House.
Plot no.360, TPS 5, Service road, Vile parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186057 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrRHJani |
| Designation |
Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot no.360, TPS 5, Service road, Vile parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186057 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrRHJani |
| Designation |
Sr Vice President |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House
Plot no.360, TPS 5, Service road, Vile parle (East)
Mumbai
MAHARASHTRA
400057
India |
| Phone |
91-22-26186057 |
| Fax |
91-22-26151735 |
| Email |
rhjani@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Zydus BSV Pharma Private Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Zydus BSV Pharma Private Limited |
| Address |
Zydus BSV Pharma Private Limited
Zydus Tower,
SG Highway
Satellite Cross Roads,
Ahmedabad-380015
|
| 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 = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr B K Shewalkar |
Govt. Medical College and Hospita |
Dept. of Radiotherapy and Oncology, Govt. Medical College and Hospital, Jublee Park, Aurnagabad
Aurangabad
MAHARASHTRA |
09850632639
bkrish_e@rediffmail.com |
| Dr Vinod Raina |
All India Institute of Medical Sciences (AIIMS) |
Department of medical oncology, All India Institute of Medical Sciences (AIIMS), New Delhi- 110029
New Delhi
DELHI |
011-26593679
vinodraina@hotmail.com |
| Dr Smita Gupte |
Cancer Clinic |
Cancer Clinic, 208, Second Floor, Shrivardhan Complex, Ramdaspeth, Wardha Road, Nagpur
Nagpur
MAHARASHTRA |
9373107176
smita_gupte@rediffmail.com |
| Dr Rajnish Nagrakar |
Curie Manavata Cancer Center |
Curie Manavata Cancer Center, Opposite Mahamarg Bus Stand, Mumbai naka, Nashik- 422004
Nashik
MAHARASHTRA |
9823061929
drrajnagarkar@yahoo.co.in |
| Dr Krishnan Srinivasan |
Dr. Rai Memorial Medical Centre |
Dr. Rai Memorial Medical Centre, 562, Century Plaza, Anna Salai, Teynampet, Chennai- 600018
Chennai
TAMIL NADU |
044-24349860
krishnan_dr@yahoo.com |
| Dr Chirag Desai |
Hemato Oncology clinic, Vedanta Institute of medical services |
Hemato Oncology clinic, Vedanta Institute of medical services, Near Samved Hospital,Navrang pura, Ahmedabad-380009.
Ahmadabad
GUJARAT |
09824047561
chiragdesai.oncology@gmail.com |
| Dr. Maheboob Basade |
Jaslok Hospital |
Jaslok Hospital,15, Dr. G. Deshmukh Marg, -400 026
Mumbai
MAHARASHTRA |
09821062692
022 2352 0508
basade@gmail.com |
| Dr Unmesh Takalkar |
Kodlikeri Memorial Hospital |
Kodlikeri Memorial Hospital, #8, Manjeet Nagar, Opp. Akashwani, Jalna road, Aurangabad, Maharashtra
Aurangabad
MAHARASHTRA |
2402359406
ub.kulkarni@yahoo.com |
| Dr Sachin Hingmire |
Medipoint Hospitals Pvt |
Medipoint Hospitals Pvt. Ltd., 241/1, New D.P. Road, Aundh, Pune, Maharashtra, India
Pune
MAHARASHTRA |
02040098635
sshingmire@yahoo.com |
| Dr Chiraman Haritha |
MS Patel Cancer Centre |
MS Patel Cancer Centre, Shree Krishna Hospital, Gokal Nagar, Karamsad- 388325, Anand
Anand
GUJARAT |
91-2692-228262
ritu80@rediffmail.com |
| Dr Vibha Naik |
Naik Hospital |
Naik Hospital, Kasar Falia, Opp. Govt. Press, Kothi, Baroda
Vadodara
GUJARAT |
9825029085
doctornaik@yahoo.com |
| Dr Satya Pal Kataria |
Safdarjang Hospital, |
Senior medical specialist and head, department of medical oncology, Safdarjang Hospital, New Delhi- 110029
New Delhi
DELHI |
9868818541
spkataria@yahoo.com |
| Dr Chandrashekhar Tamane |
Sheth Nandlal Dhoot Hospital |
A1 and 2, MIDC,Chikalthana-431 210
Aurangabad
BIHAR |
0240 2489001
0240 2485331
chandratamane@yahoo.com |
| Dr Pradeep Shah |
Shreyas Medical clinic |
Shreyas Medical clinic, 2, Parimal Apartment, Nr. GPO, Baroda
Vadodara
GUJARAT |
9825040833
pradeeprshah@msn.com |
| Dr.Harsha Panchal |
The Gujarat Cancer & Research Institute |
The Gujarat Cancer & Research Institute,The Gujarat Cancer & Research Institute, New Civil Hospital Campus, Asarwa-380016
Ahmadabad
GUJARAT |
079 22688419
gcri.clinicaltrials@yahoo.co.in |
| Dr Kiran Kattimani |
The Karnataka Cancer Therapy and Research Institute, |
The Karnataka Cancer Therapy and Research Institute, Navanagar, Hubli- 580025, Karnataka.
Bangalore
KARNATAKA |
9480616656
dr_kattimani@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Astha Ethics Committe |
Approved |
| Dr. Sachin Hingmere,Penta med Ethics Committee |
Approved |
| Dr. Satyapal Kataria,Ethical committe of V M Medical college and Safdarganj Hospital |
Approved |
| Dr. Vinod Raina,Institute Ethics committee-AIIMS |
Approved |
| Dr.Kiran Kattimani,Ethical committee-The Karnatak Cancer Therapy and Research Institute |
Approved |
| Dr.Krishnan Srinivasan,(Institutional Ethics Committee-Dr RMMC-IEC) |
Approved |
| Dr.Unmesh Takalkar,Institutional review board-Kodlekeri memorial hospital |
Approved |
| Ethics Commitee of The Heart Care Clinic |
Approved |
| Global Health Concern Ethics Committee |
Approved |
| Gujarat Cancer & Research Institute/GCS Ethics Committee |
Approved |
| Human Research Ethics Committee |
Approved |
| Independent Ethics Commitee-Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Institutional Ethics Committee |
Approved |
| Jaslok Hospital & Research Center, Mumbai |
Approved |
| Manavta Clinical Research Institue |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Metastatic breast cancer, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Doxorubicin |
70mg/m2
Intravenous every 3 weeks
|
| Intervention |
Non Pegylated Liposomal Doxorubicin (NPLD) |
In Part A: Intravenous 60 mg/m2 or 70mg/m2 every 3 weeks up to 8 cycles
In Part B: NPLD (70 mg/m2 )or doxorubicin (70 mg/m2 ) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1) Female subjects aged 18 years.
2) Life expectancy of atleast 6 months at the time of enrolment.
3) Histologically confirmed metastatic breast cancer with at least one measurable lesion as determined by RECIST criteria.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5) No concurrent uncontrolled illness as determined by the investigator.
6) No other malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery).
7) Baseline left ventricular ejection fraction (LVEF) more than 50 % as determined by 2D ECHO.
8) Subjects who have not been previously treated for advanced metastatic disease. Prior adjuvant and neo-adjuvant chemotherapy is allowed if 1 year has elapsed since discontinuation of treatment.
9) If previously treated with doxorubicin and/or epirubicin in past, total lifetime exposure shall not be more than 300mg/m2 of doxorubicin or 450 mg/m2 of epirubicin.
10) Sufficient hepatic, renal and bone marrow function (Patients with elevated bilirubin and / or elevated ALT/AST will be eligible for inclusion, if reduced liver function was secondary to liver metastasis).
a. Serum bilirubin less than / equal to 1.5 x the upper limit of normal (ULN)
b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than / equal to 3 x ULN, except in the presence of hepatic metastases, where less than / equal to 5 x ULN is allowed.
c. Serum Creatinine less than / equal to 1.5 times the ULN.
d. Absolute neutrophil count greater than / equal to 1.5 x 109/L
e. Platelet count greater than / equal to 100 x 109/L
f. Haemoglobin greater than / equal to 9 g/dL
11) Patient ensuring geographical accessibility to the participating oncology centre and compliance with treatment and scheduled follow-up.
12) If the subject is of childbearing potential, she must have a negative pregnancy test at screening. (Women with childbearing potential will be advised to take adequate precautions to prevent pregnancy)
13) Subject or her legal representative has signed the informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy or breast-feeding.
2) Woman with childbearing potential with inadequate protection against pregnancy.
3) Any other uncontrolled illness.
4) Other conditions such as benign breast cancer and malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery);
5) Subject treated for advanced breast cancer in past one year.
6) Presence of active infections.
7) Presence of cerebral metastases.
8) Clinically insufficient renal, hepatic and bone marrow function.
9) Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia.
10) Early breast cancer with non-measurable lesion, rising of tumour markers, lymphangitic neoplasm or sclerosing bone lesions as the only sign of disease.
11) Patient with known or suspected Allergy to the Investigational product, other Anthracyclines, egg or egg products or any agent given in association with this trial.
12) Patients who have participated in another clinical trial study during the past 30 days or who are likely to simultaneously participate in another clinical study
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
In Part A: The primary objective of this study is to compare the overall response rate (ORR) to 60 or 70 mg/m2 of NPLD in target lesions of MBC using RECIST criteria.
In Part B: The primary objective of this study is to assess the overall response rate (ORR) to NPLD (70 mg/m2)(NUDOXA)in target lesions of MBC using RECIST criteria.
|
The evaluation will be done on visit 1, 4, 6, 8 and 10 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Part A:The secondary objectives are to evaluate the overall response rate to NPLD (60 and 70mg/m2) in non-target lesions of MBC using RECIST criteria.Part B:To evaluate the overall response rate to NPLD(70mg/m2) as compared to doxorubicin 70 mg/m2 in non-target lesions of MBC using the RECIST criteria. |
The evaluation will be done on visit 1, 4, 6, 8 and 10 for secondary objectives. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/01/2010 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Poster presentation done at Ramanbhai Foundation at Ahmedabad |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a phase II/III Open label Multicentric Randomized trial to determine the safety and efficacy of Non-pegylated Liposomal Doxorubicin (Nudoxa) at two different dose levels (60 mg/m2 or 70 mg/m2 ) NPLD as compared to doxorubicin in patients with metastatic breast cancer.
In Part A, 12 subjects will be allotted to 60 mg/m2 or 70 mg/m2 NPLD and followed upto 8th cycle for efficacy and safety and on completion of Part A, part B study will be started. The optimal selected regimen will be studied in up to 70 patients. The sample size for part B will be decided after reviewing the safety and efficacy of two regimens in MBC.
The primary objectives in Part A will be to determine the overall response rate to NPLD (60 and 70 mg/m2) in target lesions of MBC using RECIST criteria and in Part B will be to determine the overall response rate to selected dose of NPLD as compared to doxorubicin 70 mg/m2 in target lesions of MBC using RECIST criteria.
The secondary objectives in Part A will be to evaluate the overall response rate to NPLD (60mg/m2 and 70 mg/m2) in non-target lesions of MBC using the RECIST criteria and in part B will be to evaluate the overall response rate to selected dose of NPLD as compared to 70 mg/m2 doxorubicin in non target lesions of MBC using the RECIST criteria. Also the frequency and severity of adverse events (AEs) for all patients enrolled will be dtermined. The evaluation of primary and secondary variables will be done at screening and on Day 1+/- 3 days of every alternate cycle beginning with cycle 3 and at the end of the study (visit 1, 4, 6, 8 and 10) |