| CTRI Number |
CTRI/2021/07/034739 [Registered on: 09/07/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Test the Effect of the Drug Larotrectinib in Adults With NTRK-fusion Positive Solid Tumors (NAVIGATE) |
|
Scientific Title of Study
|
A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors |
| Trial Acronym |
NAVIGATE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20289 Version 10 dated 16-Dec-2020 |
Protocol Number |
| NCT02576431 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central
Avenue
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central
Avenue
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Gawde |
| Designation |
Country Medical Director |
| Affiliation |
Bayer Pharmaceuticals Private Limited |
| Address |
Bayer Pharmaceuticals Private Limited Pharmaceuticals Division
Research and Development Pharmaceuticals Bayer House Central
Avenue
Thane
MAHARASHTRA
400607
India
Thane
MAHARASHTRA
400607
India |
| Phone |
912225311201 |
| Fax |
|
| Email |
ashish.gawde@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Pharmaceutical Private Limited. |
|
|
Primary Sponsor
|
| Name |
Bayer Consumer Care AG |
| Address |
Bayer Consumer Care AG,
Peter-Merian-
Strasse 84, 4052 Basel,
Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Canada
China
Colombia
Czech Republic
Denmark
France
Germany
Greece
Hungary
India
Ireland
Italy
Japan
Norway
Poland
Portugal
Republic of Korea
Russian Federation
Singapore
Slovakia
Spain
Sweden
Taiwan
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haresh KP |
All India Institute of Medical Sciences |
Ansari Nagar
New Delhi
Central
DELHI |
8368849729
drkpharesh@gmail.com |
| Dr Kalyan Kusum Mukherjee |
Chittaranjan Cancer Research Institute |
3rd Floor, Room No-303,
Research Building,
37,S.P Mukherjee Road,
Kolkata-700026.
West Bengal,
India.
Kolkata
WEST BENGAL |
91-9830115905
kkmukherjee4u@hotmail.com |
| Dr Shruti Kate |
HCG Manavata Cancer Centre |
Department of Oncology,
First Floor, Behind Shivang Auto, Mumbai Naka,
Nashik-422002.
Maharashtra, India
Nashik
MAHARASHTRA |
917506117343
drshruti@mcrinasik.com |
| Dr Biswajit Dubashi |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER) |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)Dhanvantari Nagar, JIPMER Campus Rd, Gorimedu, Puducherry
|
918056338405
drbiswajitdm@gmail.com |
| Dr Sewanti Limaye |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute |
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Rao Saheb Achutrao Patwardhan Marg,Four Bunglows, Andheri (W)
Mumbai (Suburban)
MAHARASHTRA |
919619607339
sewanti@yahoo.com |
| Dr Vikas Ostwal |
Tata Memorial Hospital |
Homibhabha building , 11th floor , room no 1102 ,Tata Memorial Hospital, Dr Ernest Borges Road, Parel
Mumbai
MAHARASHTRA |
919702288801
dr.vikas.ostwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Chittaranjan National Cancer Institute |
Approved |
| IEC JIPMER |
Approved |
| IEC KDAH |
Approved |
| IEC TMC |
Approved |
| Institutional Ethics Committee of AIIMS New Delhi |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D493||Neoplasm of unspecified behavior of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug: BAY2757556 (Larotrectinib, Vitrakvi) |
Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Locally advanced or metastatic non-secretory breast cancer, lung cancer, melanoma, and colorectal cancer with unknown human neurotrophic tyrosine receptor kinase 1 (NTRK1), NTRK2, or NTRK3 fusion status.
Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
Subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
|
| ExclusionCriteria |
| Details |
Prior progression while receiving approved or investigational tyrosine kinase
inhibitors targeting TRK. Subjects who received less than 28 days of treatment and
discontinued because of intolerance or toxicity are eligible.
Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain
metastases are eligible to participate in the study.) Subjects with primary CNS tumors
are eligible.
Unstable cardiovascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Best overall response rate by IRC.
Proportion of subjects with either complete response or partial response as determined by an independent radiology committee (IRC) using RECIST or RANO criteria.
|
120 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with either complete response or partial response as determined by the treating investigator using RECIST or RANO criteria. |
Time Frame: Up to 120 months |
| uration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death. Complete response, partial response and disease progression are assessed by an independent radiology committee |
Time Frame: Up to 120 months |
Duration of response is the number of months from the start of confirmed complete response or partial response to disease progression or death.
Complete response, partial response and disease progression are assessed by the treating investigator |
Time Frame: Up to 120 months |
| Proportion of subjects with best overall response of complete response, partial response or stable disease lasting 16 or more weeks following the initiation of larotrectinib. |
Time Frame: Up to 120 months |
Number of months from the initiation of larotrectinib to the date of death due to any cause.
|
Time Frame: Up to 120 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="10"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/07/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2015 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. |