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CTRI Number  CTRI/2018/01/011386 [Registered on: 17/01/2018] Trial Registered Prospectively
Last Modified On: 12/09/2019
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparative study of Nilutamide 150 mg tablet  
Scientific Title of Study   A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady state Bioequivalence (BE) study of Genus Lifesciences Inc. Nilutamide Tablets 150 mg with NILANDRON ® (Nilutamide) Tablets 150 mg from Concordia Pharmaceuticals Inc. in metastatic prostate cancer patients.  
Trial Acronym  NLM101 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
17-101; Version 2.0; Dated 19/Mar/2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room NO 5, 2nd Floor, Skoda House, Opp. LJ Campus, SG Highway Sarkhej, Ahmedabad – 382210 , India

Ahmadabad
GUJARAT
382210
India 
Phone  09637555304  
Fax    
Email  sandeep.singh@vibgyorcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room NO 5, 2nd Floor, Skoda House, Opp. LJ Campus, SG Highway Sarkhej, Ahmedabad – 382210 , India


GUJARAT
382210
India 
Phone  09637555304  
Fax    
Email  sandeep.singh@vibgyorcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room NO 5, 2nd Floor, Skoda House, Opp. LJ Campus, SG Highway Sarkhej, Ahmedabad – 382210 , India


GUJARAT
382210
India 
Phone  09637555304  
Fax    
Email  sandeep.singh@vibgyorcare.com  
 
Source of Monetary or Material Support  
Genus Lifesciences Inc. 514 North, 12th Street Allentown, PA 18102 
 
Primary Sponsor  
Name  Genus Lifesciences Inc 
Address  514 North, 12th Street Allentown, PA 18102 
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 = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Shah  Bodyline Hospital  2nd Floor, Chairman Room, Opp, Annapurna Hall, New Vikas Gruh Road, Paldi Ahmedabad - 380007
Ahmadabad
GUJARAT 		 9824035673

shaileshshahuro58@gmail.com 
Dr Rajeev Sood  Dr. Ram Manohar Lohia Hospital & PGIMER   Urology Department, Room No 31, Ground Floor, OPD Block, Baba Kharag Singh Marg, New Delhi - 110001
New Delhi
DELHI 		 9810005182

drsoodr@gmail.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Center  HCG Manavata Cancer Centre, Opp Mahamarg Bus Stand, Mumbai Naka, Nashik - 422004
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercenter.com 
Dr Niraj Bhatt  Kailash Cancer Hospital & Research Center  Kailsh Cancer Hospital & Research Center, MuniSeva Ashram, Goraj-391760
Vadodara
GUJARAT 		 9925581480

niraj.bhatt@greenashram.org 
Dr Siddalingeshwar I Neeli  KLES DR. PRABHAKAR KORE HOSPITAL MEDICAL RESEARCH CENTRE  Urology Department, Nehrunagar, Belgavi - 590010, Karnataka
Belgaum
KARNATAKA 		 9880977367

sineeli@gmail.com 
Dr Anand Bhageria   Malpani Multispecialty Hospital   Clinical Research Department, Road No 1, Basement, VKI, Sikar Road, Jaipur – 302013 Rajasthan
Jaipur
RAJASTHAN 		 9829148302

ananddr7@gmail.com 
Dr Srikanth Rao  MNJ Institute of Oncology & RCC  Dept of Radio therapy, Red hills, Telangana, Hyderabad - 500004
Hyderabad
TELANGANA 		 9849009958

srikanthsaptgiri@yahoo.com 
Dr Amol Dumbre  Noble Hospital   153, Magarpattacity Road, Hadapsar, Pune - 411013
Pune
MAHARASHTRA 		 997041590

adi.medtrials@gmail.com 
Dr Neha Gupta  Sudbhawana Hospital  Clinical Research Department, Ground Floor, Room No 2, B 31/80-23 B, Bhogabir Lanka, Varanasi – 221005 U.P.
Varanasi
UTTAR PRADESH 		 8004354185

drneha500@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Bodyline Hospital Ethics Committee, Ahmedabad  Approved 
Ethics Committee, Malpani Multispeciality Hospital, Jaipur  Approved 
Ethics Committee, PGIMER Dr. RML Hospital  Approved 
Ethics Committee, Sudbhawana Hospital, Varanasi  Approved 
IEC MNJ institute of oncology & regional cancer centre  Approved 
Institutional Ethics committee, KLE  Approved 
Kailash Cancer and Medical Centre Ethics Committee, Vadodara   Approved 
Manavata Clinical Research Ethic Committee, Nashik  Approved 
Noble Hospital Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C61||Malignant neoplasm of prostate, Metastatic prostate cancer patient,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NILANDRON®(Nilutamide) Tablets 150 mg( Concordia Pharmaceuticals Inc.)   Reference Product 
Intervention  Nilutamide 150 mg tablet of Genus Lifescience Inc.  Test Product 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Male 
Details  The patients will be enrolled in the study based on the following inclusion criteria:

a) Male Patient aged 18 to 75 years having Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2

b) Patients with biopsy confirmed prostate cancer (Stage D2)

c) Patients who are already receiving 150mg of Nilutamide once a day as their individual therapy for at least 15 days prior to randomization.

d) Able to swallow and retain oral medication

e) Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

f) Life expectancy of Greater Than 180 days.

g) Acceptable hematology status:
Hemoglobin greater than or equal to 9 g/dL
Absolute neutrophil count (ANC) greater than or equal to 1500 cells/µL
Platelet count greater than or equal to 1,00,000 cells/µL

h) Acceptable liver function:
Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal (ULN)
Aspartate aminotransferase (AST) less than or equal to 2X ULN
Bilirubin less than 1.2 mg/dL
Alkaline phosphatase less than or equal to 5X ULN

i) Acceptable kidney function
Creatinine less than or equal to 2X ULN or
Creatinine clearance greater than or equal to 60 mL/minute

j) Willing and able to provide written informed consent prior to any study-related activities being performed.

k) No history of addiction to any recreational drug or drug dependence or alcohol addiction.
 
 
ExclusionCriteria 
Details  The patients will be excluded from the study based on the following exclusion criteria:

a) Hypersensitivity to Nilutamide or to any of the excipients.

b) History of major respiratory, cardiac (New York Heart Association [NYHA] Type III or IV), liver, or kidney disease.

c) Known hypersensitivity, idiosyncratic, or allergic reactions

d) In patients with severe leukopenia, neutropenia, or thrombocytopenia,


e) Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism.

f) Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.

g) Surgical or other non-healing wounds.

h) Exposure to any investigational agent within 12 weeks prior to first dose of Investigational Product.

i) History of other malignancies in the last 5 years. Potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Potential patients with other malignancies that were cured with definitive primary therapy alone (e.g., surgery) and who have been continuously free of the previous disease for 1 year are also eligible upon Sponsor approval.

j) Severe or life-threatening infection, including known past medical history of human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).

k) Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v4.03).

l) Uncontrolled diabetes mellitus.

m) Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.

n) Any other condition(s) which could significantly interfere with Protocol compliance including, but not limited to, dementia, psychosis, cognitive impairment, altered mental status, or other major psychiatric disorder.

o) Donation and/or loss of 350 ml (1 unit) of blood within 90 days prior to fist dose administration of investigational product.

p) Positive hepatitis screening laboratory tests for hepatitis B, and/or hepatitis C.

q) Patients receiving warfarin-type anticoagulants, phenytoin, propranolol, chlordiazepoxide, lidocaine, diazepam and theophylline 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the steady state bioequivalence of Genus Lifesciences Inc Nilutamide Tablets 150 mg with NILANDRON
® (Nilutamide) Tablets 150
mg from Concordia Pharmaceuticals Inc. in metastatic prostate cancer
patients
 		 Day 16 & Day 32  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of Patients.  Day 16 & Day 32 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 29/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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)?  

Brief Summary  
Metastatic prostate cancer (Stage D2) patient who are already receiving the drug at a dose of 150 mg of Nilutamide once a day as their individual therapy for at least 15 days prior to randomization meeting the above mentioned inclusion and none of exclusion criteria will be identified.  Shortlisted Patients will undergo screening not before 28 days of 1st  dosing. Eligible patients will be enrolled and randomized. 

Upon randomization, patients will receive assigned study drug dose of Nilutamide Tablets 150 mg (T or R) based on the randomization schedule in each period. Patients will receive either Test or Reference treatment as per randomization schedule in period 01 (From day 01 to day 16) and in period 02 (From Day 17 to day 32). 

Pre dose blood sample will be collected on day 14, 15, 30 and 31 prior to dosing. Study nurse/Trained personnel will explain the drug administration process on day 01 to patients. 

A total of 18 blood samples will be collected during each period of study as mention in Sampling Time-points
section. Safety sample will be collected after completion/ during last PK sample of the study (i.e. on day 33). 

Plasma concentrations of Nilutamide will be assayed by a validated LCMS/MS analytical method. 

Statistical Analysis of pharmacokinetic parameters of test and referenceformulations will be performed to assess bioequivalence. 
 
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