CTRI Number |
CTRI/2017/02/007857 [Registered on: 14/02/2017] Trial Registered Prospectively |
Last Modified On: |
23/01/2024 |
Post Graduate Thesis |
No |
Type of Trial |
PMS |
Type of Study
|
Drug |
Study Design |
Other |
Public Title of Study
|
An active surveillance to monitor the real world safety of Nintedanib in Indian NSCLC patients |
Scientific Title of Study
|
An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Pavitra Wagh |
Designation |
Manager - Local Clinical Trials |
Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
Address |
Boehringer Ingelheim India Pvt. Ltd.
1102, 11th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital, Bandra East, Mumbai
Mumbai MAHARASHTRA 400051 India |
Phone |
9967088793 |
Fax |
|
Email |
pavitra.wagh@boehringer-ingelheim.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh Naik |
Designation |
Head - Medical Oncology |
Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
Address |
Boehringer Ingelheim India Pvt. Ltd.
10th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital,
Bandra East, Mumbai
Mumbai MAHARASHTRA 400051 India |
Phone |
9930804426 |
Fax |
|
Email |
rajesh.naik@boehringer-ingelheim.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rajesh Naik |
Designation |
Head - Medical Oncology |
Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
Address |
Boehringer Ingelheim India Pvt. Ltd.
10th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital,
Bandra East, Mumbai
Mumbai MAHARASHTRA 400051 India |
Phone |
9930804426 |
Fax |
|
Email |
rajesh.naik@boehringer-ingelheim.com |
|
Source of Monetary or Material Support
|
Boehringer Ingelheim India Pvt Ltd |
|
Primary Sponsor
|
Name |
Boehringer Ingelheim India Pvt Ltd |
Address |
Boehringer Ingelheim India Pvt. Ltd.
1102, 11th Floor, Hallmark Business Plaza, Gurunanak Hospital Road, Near Gurunanak Hospital,Bandra East, Mumbai- 400051 |
Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 15 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sushant Mittal |
Action Cancer Hospital |
Action Cancer Hospital
A-4, Pashim Vihar,New Delhi- 110063
West DELHI |
9818930805
sushantmittal80@gmail.com |
Dr Indranil Ghosh |
Apollo Gleneagles Hospital |
Apollo Gleneagles Hospital Kolkata,
58, Canal Circular Road,
Kolkata-700054 Kolkata WEST BENGAL |
9163223215
dr.indraghosh@gmail.com |
Dr Rekha Bansal |
Apollo Hospitals |
Apollo Health City Hospital, Road No 72, Opp. Bharatiya Vidya Bhavan School,
Film Nagar, Jubilee Hills, Hyderabad, 500033 Hyderabad TELANGANA |
9652403953
agarwal.rekhoo@gmail.com |
Dr Senthil Jagannathan Rajappa |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Road No. 10, Banjara Hills, Hyderabad - 500 034, Andhra Pradesh, India Hyderabad ANDHRA PRADESH |
040-23551235
senthiljrajappa@gmail.com |
Dr Shekar Gowda Patil |
HCG Hospital |
HCG Towers, No:8, P. Kalinga Rao Road, Sampangirama Nagar, Bengaluru - 560027,
Karnataka, India Bangalore KARNATAKA |
9341245961
spassociates6@gmail.com |
Dr Rajankumar Mohapatra |
Institute of Oncology & BMT, SIMS |
Institute of Oncology and
BMT, SRM Institutes for
Medical Science (SIMS
Hospital), No. 1 Jawaharlal
Nehru Salai, Vadaplani –
600026, Chennai Chennai TAMIL NADU |
9840033512
realpv60@hotmail.com |
Dr Sourjya Banerjee |
KMC Hospital |
Department of Radiotherapy
and Oncology, KMC
Hospital, Attavar, Mangalore
- 575001, Karnataka Chikmagalur KARNATAKA |
9880345339
sourjya.banerjee@gmail.com |
Dr Vinayak V Maka |
M.S. Ramaiah Medical College and Hospitals |
M.S. Ramaiah Medical College and Hospitals, M.S.R.I.T Post, MSR Nagar, Bengalore Bangalore KARNATAKA |
9986618191
drvinayak.msr@gmail.com |
Dr Poonam Patil |
Manipal Hospitals |
Manipal Hospital, #98 HAL Airport Road,
Bangalore 560017 Bangalore KARNATAKA |
9945687185
poonampatil@yahoo.com |
Dr Chanchal Goswami |
Medica Superspecialty Hospital |
127 Mukundapur, E.M. Bypass
Kolkata-700099, West Bengal, India Kolkata WEST BENGAL |
033-66520000
drcgoswami@gmail.com |
Dr Pradnya Coca |
Narayana Health |
Mazumdar Shaw Medical Center, Unit of Narayana Health,
#258/A, Bommasandra Industrial Area,
Anekal Taluk, Bangalore 560099 Bangalore KARNATAKA |
8050004989
pragnya.11@gmail.com |
Dr Pankaj Goyal |
Rajiv Gandhi Cancer Institute & Research Centre |
Rajiv Gandhi Cancer Institute
and Research Centre, Sector-
V, Rohini - 110085, Delhi New Delhi DELHI |
9711996969
pankaj155@yahoo.com |
Dr Ghanashyam Biswas |
Sparsh Hospitals & Critical Care (P) Ltd |
Plot No. A/407, Sahid Nagar, Bhubaneswar – 751007, Odisha, India Khordha ORISSA |
0674-2540183
drghanshyambiswas@gmail.com |
Dr Nikhil S Ghadyalpatil |
Yashoda Hospital |
Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad - 50082 Hyderabad ANDHRA PRADESH |
8008037474
nikhilghadyalpatil@gmail.com |
Dr Mithun Shah |
Zydus Hospital & Healthcare Research Pvt. Ltd. |
Zydus Hospitals and
Healthcare Research Pvt.
Ltd., Zydus Road Off. S. G.
Highway, Thaltej,
Ahmedabad – 380054,
Gujarat Ahmadabad GUJARAT |
9879770127
mithunshah@zydushospitals.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 15 |
Name of Committee |
Approval Status |
Action Cancer Hospital Ethics Committee |
Approved |
Clinical research ethics committee – Medica Superspecialty Hospital, Kolkata |
Approved |
Ethics Committee – M S Ramaiah Medical College and Hospital, Bangalore |
Approved |
Ethics Committee of Manipal Hospitals, Bangalore |
Approved |
HCG Central ethics committee, Bangalore |
Approved |
Institutional Ethics Committee - clinical studies, Apollo Hospitals, Hyderabad |
Approved |
Institutional Ethics Committee – BIACH & RI, Hyderabad |
Approved |
Institutional Ethics Committee – YAMER, Hyderabad |
Approved |
Institutional Ethics Committee SRM |
Approved |
Institutional Ethics Committee, Apollo Gleneagles, Kolkata |
Approved |
Institutional Ethics Committee, Sparsh Hospital & Critical Care, Bhubaneswar |
Approved |
Institutional Review Board Rajiv Gandhi Cancer Institute & Research Centre, |
Approved |
Manipal University Ethics Committee, Mangalore |
Approved |
Narayana Health Medical Ethics Committee, Bangalore |
Approved |
Zydus Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
Status |
No Objection Certificate |
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
NSCLC (Non Small Cell Lung Cancer), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nintedanib |
This is not an interventional study but this is an active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. Patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included and that baseline characteristics of 100 additional patients (or as many patients as in the nintedanib group if 100) planned to be treated with single agent docetaxel are collected from the same centers during the same time frame, or until a maximum of two years, whichever occurs first. |
Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1. Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert.
2. Willing to provide the informed consent
3. Patients in whom further visit/contact is possible during the planned period of active surveillance
4. Patients in whom information mentioned in the section 9.2.2.2 of the protocol is available |
|
ExclusionCriteria |
Details |
1. Patients who have taken nintedanib before participation in the study
2. Patients who are positive for EGFR mutation
3. Patients who are positive for ALK rearrangements
4. Patients who are participating in a clinical trial |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Occurrence of ADRs (serious and non-serious)
2. Occurrence of AEs (serious and fatal) |
2 Years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events |
2 Years |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
14/02/2017 |
Date of Study Completion (India) |
24/09/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Will be updated later. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an active surveillance to monitor the real world safety in Indian patients of locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line chemotherapy, who are newly prescribed nintedanib according to the package insert. Patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included and that baseline characteristics of 100 additional patients (or as many patients as in the nintedanib group if <100) planned to be treated with single agent docetaxel are collected from the same centers during the same time frame, or until a maximum of two years, whichever occurs first. The primary outcome: Occurrence of ADRs (serious and non-serious) Occurrence of AEs (serious and fatal) Secondary outcome: Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events |