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CTRI Number  CTRI/2018/10/015941 [Registered on: 08/10/2018] Trial Registered Prospectively
Last Modified On: 01/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
A prospective, multicentre study to see the safety of Osimertinib in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer.  
Scientific Title of Study   A prospective, multicenter, Phase-IV clinical trial to assess safety of TAGRISSO (Osimertinib) in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC) 
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
D5161C00005 , Version 1 , 06 November 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prabhat singh malik 
Address  Dr. B. R. Ambedkar Institute Rotary Cancer Hospital, Room no-245, 2nd floor, Dr. B. R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, Ansari Nagar, New Delhi

New Delhi
DELHI
110029.
India 
Phone  9968325318  
Fax    
Email  drprabhatsm@gmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Mangesh Sheshrao Kamle 
Address  AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore

Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  mangesh.sheshraokamle@astrazeneca.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Amit Kumar  
Address  AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore

Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  amit.kumarak@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Limited 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Limited 
Address  Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore-560045 
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 = 8  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Prabhat Singh Malik  All India Institute Of Medical Sciences  Dr B R Ambedkar Institute Rotary Cancer Hospital Room no 245 2nd floor Dr B R Ambedkar Institute Rotary Cancer Hospital AIIMS Ansari Nagar New Delhi 110029
New Delhi
 
9968325318

drprabhatsm@gmail.com 
Dr M Vamshi Krishna  Apollo Cancer Institute  Jubilee Hills Hyderabad 500096
Hyderabad
 
9959778112

drmvkrishnaonco@gmail.com 
Dr Senthil Rajappa  Basavatarakam Indo-American Cancer Hospital and Research Institute  Basavatarakam Indo-American Cancer Hospital and Research Institute Road No 14 Banjara Hills
Hyderabad
 
9849213102

drshyam_aggarwal@yahoo.com 
Dr Sewanti Limaye  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  2nd floor Medical Research Department
Mumbai
 
9619607339

sewanti@yahoo.com 
Dr Ullas Batra  Rajiv Gandhi Cancer Institute & Researcg Centre  Room No 2251 Rajiv Gandhi Cancer Institute and Research Centre Sector V Rohini New Delhi
New Delhi
 
9711080001

ullasbatra@gmail.com 
Dr Shyam Aggarwal  Sir Ganga Ram Hospital   Rajinder Nagar New Delhi 110060
New Delhi
 
9811075870

drshyam_aggarwal@yahoo.com 
Dr Deepak Dabkara  Tata Medical Center  Medical Oncology Room No 23 14 Tata Medical Center MAR(E-W) New Town
Kolkata
 
8697268292

deepakdabkara@yahoo.com 
Dr Vanita Noronha  Tata Memorial Center  Department of Medical Oncology HBB Bock Room no 304 3rd floor Dr E Borges road Parel Mumbai
Mumbai
 
9769328047

vanita.noronha@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Institute Ethics Commitee All India Institute Of Medical sciences  Approved 
Institutional Ethics Committee Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Approved 
Institutional Ethics Committee Tata Memorial Hospital   Approved 
Institutional Ethics Committee, Apollo Cancer Institute  Approved 
Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital and Research Institute  Approved 
Institutional Ethics Committee, Sir Ganga Ram Hospital  Approved 
Institutional Ethics Committee, Tata Medical Center, Kolkata  Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC) 
Patients  Malignant neoplasm of upper lobe,bronchus or lung 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Patient of either sex and ≥18 years of age
2 Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
3 Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF). 
 
ExclusionCriteria 
Details  Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
2 Pregnant and/or lactating women
3 Patients participating in any current or future interventional trial will not be enrolled in the current study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deaths  NA 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/10/2018 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Brief Summary  
This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC. Investigator will be trained on the locally approved prescribing information before the enrolment of the first patient at their site to ensure compliant and proper dosing of the study drug. Patients will be monitored throughout the study period for AEs of osimertinib.
The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.
 

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