| CTRI Number |
CTRI/2019/06/019649 [Registered on: 12/06/2019] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-A |
|
Scientific Title of Study
|
A Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-A in patients with recurrent Head and Neck Squamous Cell Carcinoma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NAT2694P2 Version V, Date December 12, 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kumar Prabhash |
| Designation |
Head of the Department of Solid Tumor (Adult) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Head of the Department of Solid Tumor (Adult)
OPD-204, 2nd floor
Homi Bhabha Block
Department of Medical Oncology
Tata Memorial Hospital
Dr. Ernest Borges Marg
Parel Mumbai
Head of the Department of Solid Tumor (Adult)
OPD-204, 2nd floor
Homi Bhabha Block
Department of Medical Oncology
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
kprabhash1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen C Myneni |
| Designation |
Medical Officer and Principal Scientist |
| Affiliation |
NATCO Pharma Ltd |
| Address |
NATCO Pharma Ltd
NATCO House
Road No. 2 Banjara Hills
Hyderabad
NATCO House
Road No. 2 Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
Drpraveen@natcopharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Venkat Ramana |
| Designation |
Principal Scientist and Coordinator – Drug development |
| Affiliation |
NATCO Pharma Ltd |
| Address |
NATCO Pharma Ltd
NATCO House
Road No 2 Banjara Hills
Hyderabad
NATCO Pharma Ltd
NATCO House
Road No 2 Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
gvramana@natcopharma.co.in |
|
|
Source of Monetary or Material Support
|
| NATCO Pharma Limited, NATCO House, Road No. 2, Banjara Hills, Hyderabad - 500 034 |
|
|
Primary Sponsor
|
| Name |
NATCO Pharma Ltd |
| Address |
NATCO House
Road No. 2 Banjara Hills
Hyderabad 500034
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 22 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lovenish Goyal |
Aadhar Health Institute |
Tosham Road Near South Bypass Crossing Hisar 125005
Hisar
HARYANA |
9896539142
drlovenish@gmail.com |
| Dr Aditi Mittal |
Apex Hospitals Private Limited |
SP-4 & 6 Malviya Industrial Area Near Apex Circle Malviya Nagar Jaipur 302017
Jaipur
RAJASTHAN |
9414303668
draditimittal719@gmail.com |
| Dr Prashant Mehta |
Asian Institute of Medical Sciences |
Department of Medical Oncology, Sec-21 A, Faridabad - 121001
Faridabad
HARYANA |
9599460474
prashantcipher7@gmail.com |
| Dr Surender Kumar Beniwal |
ATRCTRI (RCC) |
Medical Oncologist
Department of Medical Oncology
ATRCTRI (RCC)
S.P Medical College & AG of Hospitals
Bikaner 334003
Bikaner
RAJASTHAN |
09414370484
beniwal.surendra@gmail.com |
| Dr Tanmoy Kumar Mandal |
Binayak Multi-Speciality Hospital |
Binayak Enclave, 59, Kali Charan Ghosh Road, Kolkata- 700050
Kolkata
WEST BENGAL |
9051238499
tanmoy.nrs@gmail.com |
| Dr Ravi Kannan |
Cacher Cancer Hospital and Research Centre |
Meherpur, Birbal Bazar, Silchar, Assam 788015
Cachar
ASSAM |
9854040424
ravi.kannan@cacharcancerhospital.com |
| Dr Ashwin Oomen Philips |
Christian Medical College and Hospital |
Department of Medical Oncology
Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab - 141008
Ludhiana
PUNJAB |
9003635373
0161-2606957
drashphilsmog@gmail.com |
| Dr Chetan Deshmukh |
Deenanath Mangeshkar Hospital and Research Center |
Near Mhatre Bridge, Karve Road, Erandawane, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
9850811449
drchetandeshmukh@gmail.com |
| Dr Muralidhar Bora |
HCG Cancer Centre |
Plot No: 10, Survey No 13P APIIC Health City Arilova Visakhapatnam – 530040
Visakhapatnam
ANDHRA PRADESH |
9490909437
mrlydhar@gmail.com |
| Dr A Satya Srinivas |
HCG City Cancer Centre |
HealthCare Global Enterprises Ltd
33-25-33
Ch Venkata Krishnayya Street Suryaraopet Vijayawada 520002
Krishna
ANDHRA PRADESH |
9176715256
dr.satyasrinivas@gmail.com |
| Dr Rajnish Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang Auto
Mumbai Naka
Nashik – 422002 Maharashtra
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Susanta Kumar Paikaray |
HCG Panda Cancer Hospital |
NH16 Telengapentha Cuttack-754001
Cuttack
ORISSA |
9437147517
drskppgi@gmail.com |
| Dr Pratap Kishore Das |
Indraprastha Apollo Hospitals |
Sarita Vihar, Mathura road, New Delhi 110076
New Delhi
DELHI |
9810444600
drpratapdas@gmail.com |
| Dr Santhosh Vandanasetti |
Kailash Cancer Hospital and Research Center |
Muniseva Ashram, Goraj, Waghodia, Vadodara-391760
Vadodara
GUJARAT |
9427423693
Vandanasetti.santhosh@greenashram.org |
| Dr Maheshkumar Kalloli |
KLES Dr. Prabhakar Kore Hospital and Medical Research Center |
KLES Dr. Prabhakar Kore Hospital and Medical Research Center
Nehru Nagar Belgaum – 590010
Belgaum
KARNATAKA |
9945014996
mahesh.kalloli@gmail.com |
| Dr Rajani Priya Yedla |
Mahatma Gandhi Cancer Hospital and Research Institute |
1/7 MVP Colony, Visakhapatnam - 530017
Visakhapatnam
ANDHRA PRADESH |
9640953911
drrajinipriya@gmail.com |
| Dr Krishna Kumar Rathnam |
Meenakshi Mission Hospital and Research Centre |
Lake Area Melur Road- 625107
Madurai
TAMIL NADU |
9380417299
kkrathnam@gmail.com |
| Dr Chinmay Kumar Bosu |
Netaji Subhash Chandra Bose Cancer Hospital |
3081, Nayabad, Kolkata 700094
Kolkata
WEST BENGAL |
9830114880
nscbcri2017@gmail.com |
| Dr Sadashivudu Gundeti |
Nizams Institute of Medical Sciences |
Additional Professor and head Department of Medical Oncology
Nizam’s Institute of Medical Sciences Panjagutta
Hyderabad
TELANGANA |
00914023489089
drssgundeti@yahoo.com |
| Dr Kaushalkumar B Patel |
Shree Mahavir Health& Relief Society |
Smt. R. B. Shah Mahavir Super Speciality Hospital & Shri B. D. Mehta Mahavir Heart Institute Shree Mahavir Health Campus Athwagate Nanpura Surat 395001
Surat
GUJARAT |
9723431102
kpatel291980@yahoo.com |
| Dr Ghanashyam Biswas |
Sparsh Hospitals & Critical Care (P) Ltd |
Plot NO A/407 Sahid Nagar
Bhubaneswar 751007
Odisha
Khordha
ORISSA |
09937500878
drgbiswas@gmail.com |
| Dr Kumar Prabhash |
Tata Memorial Hosiptal |
Head of the Department of Solid Tumor (Adult)
OPD-204 2nd floor
Homi Bhabha Block
Department of Medical Oncology
Tata Memorial Hospital
Dr. Ernest Borges Marg Parel
Mumbai
MAHARASHTRA |
022-24177000
kprabhash1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 23 |
| Name of Committee |
Approval Status |
| Aadhar Institutional Ethics Committee |
Approved |
| Asian Institute of Medical Sciences Ethics Committee |
Approved |
| Ethics Committe |
Submittted/Under Review |
| Ethics Committee NSCBC Research Institute |
Approved |
| Ethics Committee-II |
Submittted/Under Review |
| Institutional Ethics Committe |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee- Clinical Studies |
Approved |
| Institutional Ethics Committeee |
Approved |
| Institutional Ethics Committe_HCG Curie City Cancer Centre |
Approved |
| Institutional Review Board |
Approved |
| Mahatma Gandhi Cancer Hospital & Research Institute Institutional Review Board |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
| Nims Institutional Ethics Committee |
Approved |
| Shri B DMehta Mahavir Heart Institute Ethics Committee |
Approved |
| The Institutional Ethics Committee Binayak Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cisplatin/ Carboplatin and 5FU which are standard chemotherapeutic agents |
Cisplatin On Day-1 of Cycle 1 to Cycle 6 OR
Carboplatin On Day-1 of Cycle 1 to Cycle 6
Flurouracil Day 1 to Day 4 of Cycles 1 to 6
|
| Intervention |
NRC-2694-A Tablet |
NRC-2694-A will be given with standard chemothearpy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients must be between 18 and 65 years of age with life expectancy ≥ 3 months having recurrent and/or metastatic disease.
2. ECOG Performance Status less than or equal to 2.
3. Histologically confirmed squamous cell carcinoma of the head and neck. Primary sites include, oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus.
4. Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count ≥2000/mm3, platelet count ≥ 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level ≤2 times upper normal limit (UNL) and serum transaminases levels ≤ 2.5 times UNL/ ≤ 5 times for liver metastasis and/or obstructive jaundice].
5. Patients must not have received chemotherapy within 30 days (6 weeks for nitrosoureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing.
6. Measurable lesion as per Revised RECIST criteria (1.1 version)
7. Subjects who received primary radiation therapy are eligible if the locoregional recurrence is in the field of radiation and occurred at least 6 months after therapy completion. If the recurrence is outside the field of radiation, subject will be eligible at least 3 months after therapy completion.
8. Willing to practice birth control during and for 2 months after treatment.
9. Patients must be tested negative for HIV, HbsAg and pregnancy (for female subjects).
|
|
| ExclusionCriteria |
| Details |
1. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy
2. Patients with brain metastases or primary CNS malignancies. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms
3. Prior EGFR-targeting therapies, prior investigational agents for recurrent or metastatic disease, other concurrent investigational agents, other concurrent anticancer treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Tumor response will be assessed by CT or MRI at baseline and at end of every 6-week (Before start of Preceding cycle) after the start of treatment until disease progression |
1, 42, 84 and 216 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival is defined as the time from the date of randomization to the date of death (regardless of the cause of death combines). Percentage of patients in each arm achieving Objective response (complete and partial response), duration of response (DOR; time from first confirmed object response to disease progression), time to response (TRR; time from randomization to first confirmed objective response) |
day 1 and day 216 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
17/06/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted in patients
with recurrent or metastatic squamous-cell carcinoma of the head and neck and
for whom cisplatin/carboplatin and fluorouracil regimen is planned. The primary objective of the study is to evaluate the efficacy of NRC-2694-A tablets when combined with platinum regimen compared to
platinum regimen alone in terms of Progression Free Survival (PFS). The secondary objective is to compare the objective
response, stable
disease rates, duration of response, time to response, median survival, overall survival of patients and safety & tolerability of the study drug. |