| CTRI Number |
CTRI/2024/01/061126 [Registered on: 04/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using the Right Dose of Gefitinib medicine for Better Treatment in Lung Cancer |
|
Scientific Title of Study
|
Precision Therapy of Gefitinib in Non-Small Cell Lung Cancer Patients: An Integrated Pharmacogenomic and Population Pharmacokinetic Approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahadev Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
Room No: 9
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
4th floor, MCODS via New OPD block, Kasturba Hospital
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadev Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
Room No: 9
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
4th floor, MCODS via New OPD block, Kasturba Hospital
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105706060 |
| Fax |
|
| Email |
mahadev.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Miss Prathvi V Shenoy |
| Designation |
Ph.D. Research Scholar |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE, Manipal |
| Address |
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
4th floor, MCODS via New OPD block, Kasturba Hospital
Manipal Academy of Higher Education (MAHE)
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9482420251 |
| Fax |
|
| Email |
prathvi.shenoy2@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Intramural Fund, Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Intramural Funding, MAHE, Manipal |
| Address |
Manipal Academy of Higher Education (MAHE)
Manipal - 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahadev Rao |
Kasturba Medical College and Hospital, Manipal |
Room No 9, Department of Pharmacy Practice,
4th flood MCODS, via New OPD block, Kasturba Hospital, MAHE, Manipal
Udupi
KARNATAKA |
8105706060
mahadev.rao@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C343||Malignant neoplasm of lower lobe,bronchus or lung, (2) ICD-10 Condition: C340||Malignant neoplasm of main bronchus, (3) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, (4) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung, (5) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (6) ICD-10 Condition: C341||Malignant neoplasm of upper lobe,bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-Small Cell Lung Cancer patients (both males and females) with EGFR positive mutation.
2. Age group of 18-80 years.
3. Patients who are willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. HIV positive patients.
2. Patients with seriously ill conditions (eg: COVID 19 etc.,) or clinically unstable patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The current research aims to develop an appropriate gefitinib population pharmacokinetic model for deriving an individualized gefitinib dosing strategy for NSCLC patients in tertiary care hospitals. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of such a Population pharmacokinetic model for gefitinib will aid in the implementation of precision therapy for the management of NSCLC. Thus, this study would comprehensively analyse precision therapy of lung cancer patients in our settings. |
3 years |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In our study, we intend to collect the blood samples of lung cancer patients and record the associated demographic and clinical details. The pharmacogenomic analysis will be conducted using these samples, where we intend to look at the single nucleotide polymorphisms in genes that are associated with chemotherapeutic toxicities and the efficacy of gefitinib. A non-linear mixed effect population pharmacokinetic model will be generated. |