CTRI/2024/09/074142 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On:
08/04/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
To measure the amount and the rate at which niraparib is absorbed from the niraparib 200 mg tablets and becomes available in body of cancer patients advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal cancer.
Scientific Title of Study
A Randomized, Open-label, Multi-center, Balanced, Three-period, Three-sequence, Three-way cross-over, Steady-state, Bioequivalence, Comparative Study of Niraparib 200mg Tablets of Sun Pharmaceutical Industries Limited with ZEJULA (Niraparib) 200mg Tablets of GlaxoSmithKline, Durham, NC and ZEJULA (Niraparib) 100mg Tablets (2 x 100mg tablet) of GlaxoSmithKline, Ireland, in First-Line Maintenance Treatment of Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer patients under Fasting Conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
SPL-001-NIR-OVC, version 1.0 Protocol date 17-Apr-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kanchan Tyagi
Designation
Senior Manager
Affiliation
Sun Pharmaceutical Industries Limited
Address
Research and Development Centre Vill Sarhaul, Sector 18
Gurgaon HARYANA 122015 India
Phone
9810535518
Fax
Email
kanchan.tyagi@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Rachna Arora
Designation
Senior Manager
Affiliation
Sun Pharmaceutical Industries Limited
Address
R & D Centre - Clinical Pharmacology Unit, 2nd Floor
HAH-Centenary Hospital, Jamia Hamdard
South DELHI 110062 India
Phone
9818001209
Fax
Email
rachna.arora@sunpharma.com
Details of Contact Person Public Query
Name
Dr Sudarshan Kumar
Designation
Deputy General manager
Affiliation
Sun Pharmaceutical Industries Limited
Address
Research and Development Centre Vill Sarhaul, Sector 18.
Gurgaon HARYANA 122015 India
Phone
9910445548
Fax
Email
sudershan.kumar@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited, Research & Development Centre, Sarhaul, Sector-18, Gurugram – 122015, Haryana, India
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited
Address
M/s Sun Pharmaceutical Industries Limited Tandalja Vadodara - 390012 Gujarat
Ground floor, 71/1, Humayun Kabir Sarani, Block G,
New Alipore, Kolkata, West Bengal 700053, India Kolkata WEST BENGAL
9804290687
2drprashant@gmail.com
Dr Suresh Kumar
Deepa Hospital (Indian Cancer Centre)
Room No. - 05, Ground Floor, Deepa Hospital (Indian Cancer Centre) 486, 2nd St Stanes Road, KNP Puram, Odakkadu, Tiruppur- 641602, Tamil Nadu, India Coimbatore TAMIL NADU
9487018787
drrsk21@gmail.com
Dr Kandappan Velavan
Erode Cancer Centre
Ground Floor, OPD 1, 1/393, Velevam Nagar, Near Chintamani Petrol Bunk Perundurai Road, Thindal Medu, Thindal Erode- 638012, Tamilnadu, India.
Erode
TAMIL NADU Erode TAMIL NADU
Kiran Multi Superspeciality Hospital and Research Centre
Room no. 01 and 02, 1st Floor, Oncology department, Nr. Sumul dairy, Surat-395004, Gujarat, India Surat GUJARAT
9428638448
drpriyalrsavaliya@gmail.com
Dr Nilesh Ashok Dhame
Kohlapur Cancer Centre
Room no. 1, A/p. R. S. No. 238, opp. Mayur Petrol Pump, Gokul Shirgaon, Maharashtra 416234 Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Krishna Kumar Rathnam
Meenakshi Mission Hospital & Research Centre
Department of Hemato and Medical Oncology, Room no. 344, Lake Area, Melur Main Rd, Madurai, Tamil Nadu 625107 Madurai TAMIL NADU
9380417299
kkrathnam@gmail.com
Dr Parimkayala Radhika
MNJ Institute of Oncology & Regional Cancer Center
Department of Oncology, Room No. 7 and 8, Red Hills, Hyderabad-500004, Telangana, India Hyderabad TELANGANA
9848792682
radhika.parimkayala@gmail.com
Dr Prakash SS
Mysore Medical College and Research Institute
Dept. of Surgical Oncology,
Room No. 23, Ground Floor,
Next to Dept. Radiology,
K.R. Hospital,
Irwin Road, Mysore-570001, Karnataka Mysore KARNATAKA
9901000559
prakashyesyes@yahoo.com
Dr Minish Jain
Noble Hospitals Pvt. Ltd.
Room No. 31, Department of Oncology, Noble Hospitals & Research Centre, 153, Magarpatta Rd, Magarpatta, Hadapsar, Pune, Maharashtra 411013 India Pune MAHARASHTRA
9823133390
minishjain009@gmail.com
Dr Anil Kumar MR
Oncoville Cancer Hospital and Research Centre
Room no. 1, Ground floor, No. 4, 80 ft. road, 7th Block, Nagarabhavi, 2nd Stage, Bengaluru, Karnataka-560072, India Bangalore KARNATAKA
Institutional Ethics Committee Erode Cancer Centre Private Ltd 1/393, Velavan Nagar, Perundurai Road, Thindal Erode Tamil Nadu - 638012
Approved
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre Lake Area Melur Road Madurai Madurai Tamil Nadu- 625107
Approved
Institutional Ethics Committee HCG Cancer Centre, HCG Cancer Centre Plot No. 10, Survey No. 13P APIIC Health City, Arilova, Chinagadili, Visakhapatnam, Andhra Pradesh 530040
Approved
Institutional Ethics Committee Kailash Cancer Hospital And Research Center, Kailash Cancer Hospital And Research Center, Muni Seva Ashram, Goraj, Waghodia, Gujarat - 391760 India
Approved
Institutional Ethics Committee of OCH and RC, Oncoville Cancer Hospital & Research Centre, No. 4, 80 ft. road, 7th Block, Nagarabhavi, 2nd Stage, Bengaluru, Karnataka-560072, India
Noble Hospital Institutional Ethics Committee, Noble Hospitals & Research Centre 153, Magarpatta Rd, Magarpatta, Hadapsar, Pune, Maharashtra 411013 India
Approved
Universal Ethics Committee, Aurous HealthCare Research Development India PL 180/109 G1 and G2, RR Villa, Rangarajapuram Main Road, Kodambakkam Chennai Chennai Tamil Nadu - 600024 India
Two tablets of ZEJULA (Niraparib) Tablets 100mg of GlaxoSmithKline, Ireland, to be taken once daily, for total of 12 days.
Intervention
Test Product (T):
Niraparib Tablets 200mg
One tablet of Niraparib 200 mg to be taken daily for total of 12 days, manufactured by of Sun Pharmaceutical Industries Limited, India
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
1. Female patients of 18 to 75 years (both inclusive) at the time of signing the informed consent form.
2. Patients with documented advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
3. Patients must have received their most recent platinum-containing regimen within 12 weeks prior to initiating Niraparib treatment.
4. Patients with weight of less than 77 Kg (less than 170 lbs) or with a platelet count less than 150,000/μL at the time of screening.
5. Patients with Eastern Cooperation Oncology Group (ECOG) performance status of 0-2 at screening
6. Patients with adequate organ function with the following laboratory criteria during screening.
 Absolute neutrophil count more than equal to 1500 per µL
 Platelets count more than equal to 100,000 per µL
 Haemoglobin more than equal to 9 g per dL
 Serum creatinine less than equal to 1.5 × ULN
 Serum total bilirubin less than equal to 1.5 × ULN
 Serum aspartate aminotransferase and alanine aminotransferase more than equal to 2.5 × ULN; more than equal to 5 × ULN in patients with liver infiltration
7. Patients with a negative test for Human Immunodeficiency Virus type I/II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies at screening.
8. Patients of childbearing age (defined as women physiologically capable of becoming pregnant) who agree to use effective contraception and not to donate eggs starting from the date of signing the informed consent form and for at least 6 months after the last dose of Niraparib.
Acceptable methods of contraception include:
 Intrauterine device or intrauterine system
 Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
 Hormonal contraception
 Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation
 Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) plus one additional contraception method.
9. Female patients of non-childbearing potential or female patients who have attained or achieved menopause which is defined as females with consecutive 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries.
10. Non-lactating patients
11. Patients of childbearing potential with a negative serum pregnancy test at Screening Part I and II, a negative urine pregnancy test at baseline/randomization visit (Day 0) and on the day of check-in of all the periods.
12. Patients with a life expectancy of more than 90 days.
13. Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction.
14. Patients who are preferably non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco-containing products at least 48.00 hours prior to first check-in until the last sample collection in each study period.
15. Patients who are willing to abstain from caffeine/xanthine-containing food and beverages (chocolates, tea, coffee or cola drinks) for at least 48.00 hours (2 days) prior to first check-in until the last sample collection in each study period.
16. Patients who are willing to abstain from alcohol or alcoholic products at least 48.00 hours prior to first check-in until the last sample collection in each study period.
17. Patients who are willing to be available for the entire study period and to comply with the protocol requirements.
ExclusionCriteria
Details
1. Patient with contraindications or hypersensitivity to Niraparib or related other PARP-1 and PARP-2 {Poly (ADP-ribose) polymerase} inhibitors such as Olaparib, Rucaparib etc.
2. Patients with a history of persistent toxicity (more than grade 2) from prior cancer therapy.
3. If patients require dose modification (other than Niraparib 200 mg daily dose) or with expected changes in concomitant medications.
4. Patients who have received palliative radiotherapy within 1 week of screening (encompassing more than 20% of the bone marrow).
5. Patients with known symptomatic, uncontrolled brain or leptomeningeal metastases.
6. Patients who have undergone any major surgery within 3 weeks before initiation of the study.
7. Patients who are receiving prohibited medications such as Anti-coagulants or drugs that reduce thrombocyte counts during the study period.
8. Patients with an active or history of cerebrovascular diseases, such as stroke, or cerebral hemorrhage within 6 months before the screening.
9. Patients who are unable to swallow orally administered drugs; or have gastric, gastro-esophageal, or esophageal cancer or any other gastrointestinal-related disorders that are likely to interfere with the absorption of investigational products.
10. Patients with a history of myelodysplastic syndrome or acute myeloid leukemia.
11. Patients who are pregnant, breastfeeding, or planning to become pregnant during this study period.
12. Patients with psychiatric or neurological disorders.
13. Patients with positive tests for urine drugs of abuse and alcohol breath test on the day of Screening Part I, Randomization Day and every check-in day.
14. Patients who consume grapefruit within 48 hours prior to first check-in and for the entire period of study.
15. Ingestion of any alcoholic beverage within the 48 hours prior to first check-in until the last PK sample collection in each study period.
16. Alcohol or substance abuse, dependence, or intoxication within the past 6 months of screening.
17. Patients with a history of difficulty in donating blood or difficulty in accessibility of veins.
18. Patients who have participated in drug research within the past 3 months before the first administration of the investigational product.
19. Patients who have donated/lost blood (more than 350 ml/1 unit) in the past 3 months before screening.
20. Patients with any condition for which, in the opinion of the investigator, it would not be in the best interest of the patient and may compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Cmax,ss, AUC0-Ï„
Day 36
Secondary Outcome
Outcome
TimePoints
1. PK endpoints: Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd,, Tmax,ss
2. Safety endpoint: Incidence of TEAEs (Treatment-Emergent Adverse Events)
At day 36
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a Randomized, Open-label, Multi-center, Balanced, Three-period,
Three-sequence, Three-way cross-over, Pharmacokinetic endpoint, Steady-state Bioequivalence
study. The study is planned to randomize 72 patients of Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
patients. The primary objective is evaluate
the bioequivalence of the Test Product i.e., Niraparib tablets 200mg of Sun
Pharmaceutical Industries Limited., India in comparison with the Reference Products,
ZEJULA (Niraparib) tablets of GlaxoSmithKline. The secondary objective is to monitor
the safety and tolerability of the patients during
the study.
The study will
be conducted in multiple clinical centers in India wherein sufficient patients
will be screened to randomize 72 patients to have 54 evaluable patients’ data for the
statistical analysis. Additional patients may be recruited in case the number of 54 evaluable patients is not achieved due to dropout/withdrawals, after agreement
with the Sponsor.
The
total expected study duration will be approximately 58 days consisting of Screening
Part I: Up to 07 days; Stabilization Phase: At least 07 days. Patients who meet the screening requirement
will be stabilized on Niraparib with a dosage regimen of Niraparib 200 mg once
daily. This will be followed by a screening Part II - Up to 07 days wherein Patients
who have undergone the stabilization phase will enter Screening Part II. The treatment
Period is of 36 days (Period-I: Day 1 to 12; Period-II: Day 13 to 24,
Period-III: Day 25 to 36). The end of Treatment Assessment will be done on on
Day 37 after the last PK sample collection