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CTRI Number  CTRI/2023/04/051951 [Registered on: 25/04/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Open Label 
Study Design  Single Arm Study 
Public Title of Study   Clinical study assessing safety and effectiveness of medicine containing two antiemetic drugs (Fosnetupitant 235 mg and Palonosetron 0.25 mg) when they are administered intravenously to prevent nausea and vomiting in cancer patients receiving chemotherapy cycles.  
Scientific Title of Study   An open label, single arm, multicenter, prospective study to evaluate safety and effectiveness of Akynzeo® I.V. [Fosnetupitant 235 mg and Palonosetron 0.25 mg (concentrate for solution for infusion)], in the prevention of chemotherapy induced nausea and vomiting (CINV) in Indian patients (STOP-CINV study) 
Trial Acronym  STOP-CINV 
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2022/008/IV Version 2.0 dated 07-Dec-2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Bhushan 
Designation  Senior Manager-Clinical Studies 
Affiliation  Glenmark Pharmaceuticals Limited 
Address  Glenmark Pharmaceuticals Limited Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E)

Mumbai
MAHARASHTRA
400099
India 
Phone  8800352225  
Fax    
Email  sumit.bhushan@glenmarkpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Bhushan 
Designation  Senior Manager-Clinical Studies 
Affiliation  Glenmark Pharmaceuticals Limited 
Address  Glenmark Pharmaceuticals Limited Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E)

Mumbai
MAHARASHTRA
400099
India 
Phone  8800352225  
Fax    
Email  sumit.bhushan@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Kumar 
Designation  Chief Executive Officer 
Affiliation  CliniExperts Research Services 
Address  Plot no 5, unit no 325, City Centre Mall, Sector 12 Dwarka, Dwarka, New Delhi

West
DELHI
110075
India 
Phone  9999219448  
Fax    
Email  ashwini.kumar@cliniexpertsresearch.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited, Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai 400099 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Limited 
Address  Glenmark Pharmaceuticals Limited, Glenmark Corporate Enclave, BD Sawant Marg, Chakala, Off WE Highway, Andheri (E), Mumbai 400099 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Siddhartha Nanda  AIIMS,Raipur  All India Institute of Medical Sciences, Room No. 01, B-BLock, Basement area, Department of Medical Oncology, Gate no 01, G.E. Road, Tatibandh
Raipur
CHHATTISGARH 		 9713711888

sidnanda@yahoo.com 
Dr Pragya Shukla  Delhi State Cancer Institute  O1-6- GTB Hospital Complex, Near Gate Number-8, GTB Hospital Complex, Dilshad Garden, GTB Enclave, Dilshad Garden, East, Delhi - 110095
East
DELHI 		 9999399466

pragyaonco@gmail.com 
Dr Abhinandan Hanji  Hanji Cancer Hospital  Hanji Cancer Hospital, Fllor 1, Mangalwarpeth, Tilakwadi, Belagavi, 590006
Belgaum
KARNATAKA 		 9945448090

drabhinandanhanji@gmail.com 
Dr Shaunak Valame  Jawahar Lal Nehru cancer Hospital and Research Centre   P.B, No. 32, Cancer Hospital Rd, Idgah Hills, Bhopal, Madhya Pradesh 462001
Bhopal
MADHYA PRADESH 		 9753339462

shaunak_valame@hotmail.com 
Dr Naval Kishore Shakya   Lakshya Cancer Hospital  Room no. 2, 1st Floor, Oncology Department, E-2/5, Amrapali Yojana, Near DPS Sitapur Road.
Lucknow
UTTAR PRADESH 		 8381925742

hospi.lakshya@yahoo.com 
Dr Arun Kumar Verma  Subharti Medical College and Hospital  Department of Oncology, Subhartipuram, Delhi-Haridwar Meerut Bypass road, NH-58, Meerut-250005
Meerut
UTTAR PRADESH 		 9958395926

radiationoncology@subharti.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee Jawahar Lal Nehru Cancer Hospital and Research Centre  Approved 
Institutional Ethics Committee, AIIMS  Approved 
Institutional Ethics Committee, Delhi State Cancer Institute  Approved 
Lakeview Ethics Committee  Approved 
Subharti Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R112||Nausea with vomiting, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient is scheduled to receive their first chemotherapy cycle of a highly
emetogenic or a moderately emetogenic chemotherapy (HEC/MEC).
2. Male/female patients aged above more than or equal to 18 years to less than or equal to 75 years
3. Willing to be part of study and for follow up.
4. Willing to provide written informed consent form.  
 
ExclusionCriteria 
Details  1. Patients with serious cardiovascular disease history or predisposition to
cardiac conduction abnormalities or use of medication which can cause
conduction abnormalities as per treating physicians’ assessment.
2. Vomiting, retching, or more than no significant nausea within 24 h before
the informed consent.
3. Women of child bearing potential who are pregnant, planning to becoming
pregnant or breast feeding.
4. Known contraindication to the intravenous administration of 50 mL 5%
glucose solution prior to index date
5. Hypersensitivity to active substances or excipients of Akynzeo® I.V.
6. Patient currently enrolled in another clinical trial.
7. Patients requiring multi-day chemotherapy
8. Patients who are prescribed other NK1RA and 5 HT3 RA 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Number of patients with drug related treatment emergent adverse events (TEAEs) as
assessed by the treating physician
-Number of patients with TEAEs
-Number of patients with Serious TEAEs (STEAEs)
 		 [Time Frame: up to 240 hr (10 days]
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Complete response rate (CR: no emesis, no rescue medication) during acute phase
2. Complete response rate during delayed phase
3. Complete response rate during the overall phase
4. Complete control (CC: no emesis, no rescue medication, and no nausea) during
overall phase
5. Complete protection (CP: no emesis, no rescue medication and no significant
nausea) during overall phase
6. Complete response rate during extended overall phase.
7. Severity of nausea assessed using a Visual Analogue Scale (VAS) 
1.[Time Frame: 0 to 24 hrs.(10 days)]
2.[Time Frame: 24 to 120 hrs.]
3.[Time Frame: 0 to 120 hrs.]
4.[Time Frame: 0 to 120 hrs.]

5.[Time Frame: 0 to 120 hrs.]

6.[Time Frame: 0 to 240 hrs(10 days)]
7.[Time Frame: upto 240 hr (10 days)]
 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
Final Enrollment numbers achieved (Total)= "178"
Final Enrollment numbers achieved (India)="178" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/05/2023 
Date of Study Completion (India) 26/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is a prospective, open label, multicenter, single arm, phase IV study to evaluate the safety and effectiveness of Akynzeo® I.V. in the management of patients receiving highly emetogenic chemotherapy (HEC)/ moderately emetogenic chemotherapy (MEC) regimen for the prevention of CINV among Indian patients. The study would be initiated at each site after review and approval from ethics committee (IRB/IEC). At screening & baseline, the potential patients both male, female more than or equal to 18 years of age, scheduled for first cycle of chemotherapy, will be enrolled in the study and a written informed consent would be procured before any study related procedures are undertaken. A detailed medical history will be obtained and also physical examination will be conducted for each patient by the study investigators. The clinical and laboratory assessment as per schedule of assessments (Table 2) would be performed at screening for determining the eligibility. Subjects would be administered the study drug on site by the Investigator and Visual Analog Scale (VAS) handout will be given to the patient. 
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