| CTRI Number |
CTRI/2025/07/090599 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bioequivalence study of Niraparib tablets 200 mg in female patients with ovarian, fallopian tube or peritoneal cancer. |
|
Scientific Title of Study
|
A multi-centre, open label, balanced, randomized, two-treatment, four-period, two-sequence, full-replicate, multiple-dose, steady state, pharmacokinetic endpoint bioequivalence study of Niraparib tablets 200 mg of Sandoz (test formulation) against ZEJULA (niraparib) tablet 200 mg of GlaxoSmithKline (reference product) under fasting conditions in female participants with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with positive homologous recombination deficiency (HRD). |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 24-VIN-0160, V 04 dated 28 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Patel |
| Designation |
Head - Clinical Operations |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8308843660 |
| Fax |
|
| Email |
Rakesh.Patel@veedalifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedalifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedalifesciences.com |
|
|
Source of Monetary or Material Support
|
| Lek Pharmaceuticals d.d. Verovškova ulica 57, 1526 Ljubljana, Slovenia
|
|
|
Primary Sponsor
|
| Name |
Lek Pharmaceuticals d.d. |
| Address |
Verovškova ulica 57,1526 Ljubljana, Slovenia
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Veeda Clinical Research Ltd |
Veeda Clinical Research Ltd., Shivalik
Plaza,Near I.I.M., Ambawadi Ahmedabad – 380
015,India Phone:91 079 3001 3000 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asma Pathan |
Indrani Hospital and cancer institute |
Department of Clinical Research,
Alandi Road Alandi, Devachi, Charholi Budruk, Pune, 412105
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8007167716
asmapathan124@gmail.com |
| Dr Lovenish Goyal |
Aadhar Health Institute, |
OPD 9, Tosham Road, Near South Bypass Crossing,, Hisar, Haryana-125005
Hisar
HARYANA |
9896539142
drlovenish@gmail.com |
| Dr K Velavan |
Erode Cancer Centre Private Ltd |
Department of clinical research, Room No.1/393, Velavan Nagar, Perundurai Road, Thindal- 638 012
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
| Dr Lagudu Perraju Bhaskar Bhuvan |
HCG Cancer Centre |
Department of Clinical Research Plot No. 10, APIIC Health city Arilova Chinnagadili Mudasarlova Road Visakhapatnam Andhra Pradesh – 530040.
Visakhapatnam
ANDHRA PRADESH |
9154144100
drbhaskarbhuvan.lp@hcgel.com |
| Dr Suparna Kanti Pal |
Health Point Hospital |
21, Prannath Pandit street Opposite Lansdown Paddapukar Kolkata West
Bengal – 700025
Kolkata
WEST BENGAL |
7980253154
suparna.k.pal@gmail.com |
| Dr Tushar Mule |
Marathwada Cancer Hospital & Research Institute |
Plot no. 02, Dynaneshwar nagar, In Front of Garkheda stadium,
Aurangabad 431005.
Aurangabad
MAHARASHTRA |
9820493558
drtusharmule22985@gmail.com |
| Dr P K Chaithanya |
MNJ Institute of Medical Oncology and Regional Cancer Centre |
Dept. of Medical Oncology, Redhills Road, Redhills, Lakadikapul, beside Niloufer Hospital - 500004
Hyderabad
TELANGANA |
8897199994
mnjiorccchaitanya@gmail.com |
| Dr Anil Kumar MR |
Oncoville Cancer Hospital and Research Centre |
No. 4,80 Ft Road, 7th Block, Nagarbhavi, 2nd stage - 560072
Bangalore
KARNATAKA |
9739808502
dranil.onco@gmail.com |
| Dr Anshul Agrawal |
PP Maniya Hospital Private Limited |
Dept. of Medical Oncology, Nr. Mamta Park Society- 1, Opp. Dharuka College, Varachha Main Road, Kapodra-395006
Surat
GUJARAT |
8657068668
anshul.oncology@gmail.com |
| Dr Minish Jain |
Profile Cancer Centre and Research Institute |
557A1, 15C, Jawaharlal Nehru Road, Burhanj Baug - B colony, Market Yard, Gultekadi, Pune
Pune
MAHARASHTRA |
9823133390
minishjain.nobletrials@gmail.com |
| Dr R K Kajla |
S.P. Medical College & AG of Hospitals |
Department of Surgery, S.P. Medical College & AG of Hospitals, Bikaner
334003, Rajasthan
Bikaner
RAJASTHAN |
911512226300
911512226301
drramkrishnank@gmail.com |
| Dr Lokesh K N |
SRV Agadi Hospital and Research Centre |
#35, H.Siddaiah Road, Wilson Garden,Bengaluru - 560027
Bangalore
KARNATAKA |
8971609070
drlokeshsrv@gmail.com |
| Dr Rajendra Singh Arora |
Sujan Surgical and cancer Hospital and Amrawati Co. Foundation |
52/B Shankar Nagar Main Road Amrawati, Maharstra - 444605
Amravati
MAHARASHTRA |
9823097573
rsaroradr@gmail.com |
| Dr Ankit Patel |
Sunshine Global Hospital |
Department of clinical research,
Room no. NA, Surat Dumas Road, Beside Big Bazar, Piplod Surat - 395007 GUJARAT
Surat
GUJARAT |
9825404202
drankitoncologist@gmail.com |
| Dr Deepak Kumar Singh |
Swami Harshankaranand Ji Hospital and Research Centre |
N8/237, BHU Road, D.L.W. Road, Newada, Sunderpur -221004
Varanasi
UTTAR PRADESH |
9450428608
deepak23oncologist@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Aadhar institutional Ethics committee |
Submittted/Under Review |
| AMRAVATI ETHICS COMMITTEE SUJAN SURGICAL CANCER HOSPITAL AND RESEARCH |
Approved |
| Ethics Committee, S.P. Medical College & AG of Hospitals |
Approved |
| Health Point Ethics Committee |
Approved |
| IEC Dr Mhaske Hospital and Research Centre |
Approved |
| IEC Oncoville Cancer Hospital and Research Centre |
Approved |
| Ikon Multispecialty Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE ERODE CANCER CENTRE |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE ERODE CANCER CENTRE |
Approved |
| Institutional Ethics Committee HCG cancer center |
Submittted/Under Review |
| Institutional Ethics Committee Shubham Sudbhawana Superspeciality Hospital |
Approved |
| Institutional Ethics Committee Sunshine Global Hospital |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| MNJ Institute of Oncology and Regional Cancer |
Approved |
| MNJ Institute of Oncology and Regional Cancer |
Approved |
| Narsimha Saraswati Medical Foundation Ethics Committee |
Approved |
| PP Maniya Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference Product: ZEJULA (niraparib) tablet 200 mg manufactured for GlaxoSmithKline Durham, NC 27701, USA |
Patients under fasting condition will be given one tablet (200 mg) once daily orally for 10 days. |
| Intervention |
Test Product: Niraparib 200 mg tablet manufactured by Sandoz Private Limited, India |
Patients under fasting condition will be given one tablet (200 mg) once daily, orally for 10 days. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1.Non-pregnant, non-lactating female participants with age of greater than, equal to 18 years and BMI range of 18.5 to 28 kg/m2 - both inclusive.
2.Participants with confirmed diagnosis of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with positive homologous recombination deficiency (HRD) and are eligible to receive Niraparib as maintenance therapy.
3.Participants weighing more than 48 kg that is 106 lb and less than 77 kg that is 170 lbs or with a platelet count of more than or equal to 100,000 per uL and less than 150,000 per uL
4.Participants meeting either one of the following criteria:
a.Participants with HRD-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that will be initiating treatment with Niraparib tablets 200 mg.
Or
b.Participants with HRD-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that are already receiving a stable dose of 200 mg of Niraparib for at least 12 days.
5.Participants that are non-smokers and ex-smoker - stopped using nicotine products for at least 90 days prior to study.
6.Participants that provide written informed consent for participation in the study.
7.Acceptable adequate organ and bone marrow function at screening and randomization
8.Able to take oral medication without crushing, dissolving, or chewing tablets.
9.Participants must have a life expectancy of greater than or equal to 6 months.
10.If Participants have received prior radiation therapy or surgery at least 28 days must have elapsed since completion.
11.Participants who are willing and able to comply with the protocol.
12.ECOG performance status of 0-2, both inclusive.
13.12-lead ECG with no clinically significant findings at screening.
14.Women of non-childbearing potential or Women of child bearing potential must have negative pregnancy test at screening visit and before randomization.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant, lactating or actively breastfeeding female
2.Participants requiring dosage modification or changes in concomitant medications that may affect the pharmacokinetics of niraparib.
3.Participants who are not on stable dose of Niraparib 200 mg, evaluated based on clinical and laboratory parameters after completion of at least 12 days of dose stabilization
4.Participants with known hypersensitivity or intolerance to niraparib.
5.History of other malignancies in the last 05 years.
6.Known CNS metastasis or previously treated brain metastases that required local treatment.
7.Participants has significant pleural effusion or ascites that is expected to require drainage during the pharmacokinetic phase of study.
8.If Participants has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or investigational agents. Exceptions are alopecia, Hemoglobin greater than equal to 9.0 g per dL, fatigue – less than equal to Grade 2, and peripheral neuropathy - stable less than or equal to Grade 2
9.Participants with galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption or gastrointestinal resection that is likely to interfere with drug absorption.
10.Participants taking CYP3A4 inducers or inhibitors.
11.History or current diagnosis of myelodysplastic syndrome, MDS or acute myeloid leukemia , AML.
12.Participants who have had a transfusion of-platelets or red blood cells , bone marrow suppression or Major surgery 28 days prior to first dosing in Period I.
13.Blood loss of 1 unit or 350 ml within 90 days prior to first dosing.
14.History of difficulty in accessibility of veins or intolerance to direct venipuncture.
15.History or presence of alcoholism or drug abuse.
16.Participants with psychiatric illness.
17.Receipt of an IMP within 3 months or 5 half-lives prior to dosing.
18.Participants found positive for HIV, VDRL or RPR, Hep B or Hep C at screening.
19.Severe bone injury caused by tumor occurred in the last 6 months or expected to occur in the near future.
20.Participants with moderate or severe hepatic impairment - Child Pugh Class B and C.
21.Participants with history of pulmonary embolism or venous thrombosis, arrhythmia, hypokalemia or hemorrhage.
22.Participants with history of Posterior reversible encephalopathy syndrome.
23.Participants with uncontrolled diabetes mellitus, HbA1c greater than 9 percentage.
24.Participants with uncontrolled hypertension.
25.Participants positive on Breath alcohol analyzer test.
26.Participants positive on urine test for drugs of abuse.
27.Difficulty in swallowing tablets.
28.Problems with fasting.
29.Any other medical condition or serious inter-current illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To establish the bioequivalence between Niraparib tablets 200 mg of Sandoz (test formulation) and ZEJULA (niraparib) tablet 200 mg of GlaxoSmithKline(reference product) under fasting conditions in female patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy whose cancer is associated with positive homologous recombination deficiency (HRD) |
Pre dose blood samples of 03 ml will be collected on day 1, day 7, 8 & 9 of Period I and day 17, 18 & 19 of Period III.
Post dose blood samples will be collected at on- Period I - Day 9, Period II - Day 10, Period III - Day 19 and Period IV - Day 20.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of the test product compared to reference product by monitoring adverse events. |
Safety & tolerability of the test or reference
product evaluable upto day 28 during the study |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is a four-period, full-replicate bioequivalence study of test formulation against reference product in female patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. |