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CTRI Number  CTRI/2024/04/065314 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
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 olaparib is absorbed from the olaparib 150 mg tablets and becomes available in body of cancer patients (ovarian cancer or breast cancer or pancreatic adenocarcinoma or prostate cancer). 
Scientific Title of Study   A randomized, open label, multi-center, balanced, three-period, three-sequence, three-way cross-over, steady-state, Bioavailability study of Olaparib film-coated Tablets 150 mg (2x150 mg Tablets) of Sun Pharmaceutical Industries Limited, India with LYNPARZA® (Olaparib) film-coated Tablets 150 mg (2x150 mg Tablets) of AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 in patients with ovarian cancer or breast cancer or pancreatic adenocarcinoma or prostate cancer  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CT/23/001, version no. 00 Protocol date 06-Nov-2023  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, Gurugram 122 015 Haryana India

Gurgaon
HARYANA
122015
India 
Phone  9810535518  
Fax    
Email  kanchan.tyagi@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Paragi 
Designation  Senior manager 
Affiliation  Sun Pharmaceutical Industries Limited 
Address  Sun Pharmaceutical Industries Ltd Tandalja, adodara 390 012 Gujarat India

Vadodara
GUJARAT
390012
India 
Phone  9979879171  
Fax    
Email  sanjay.paragi@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr Sudershan Kumar 
Designation  Deputy General manager 
Affiliation  Sun Pharmaceutical Industries Limited 
Address  Research and Development Centre Vill Sarhaul Sector 18, Gurugram 122 015 Haryana India

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 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanketh Kotne  HCG Cancer Centre  Plot No 10, Survey no. 13P, APIIC Health City, Chinnagadili, Arilova, Visakhapatnam - 530040, Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH 		 7019222831

drsanketh.k@hcgel.com 
Dr Lakshmi Priyadarshini K  HCG City Cancer Centre  33-25-33, CH Venkata Krishnayya street, Surya rao pet, Vijayawada - 520002, Andhra Pradesh, India
Krishna
ANDHRA PRADESH 		 9966030988

priyadarshini006@gmail.com 
Dr Santhosh Vandanasetti  Kailash Cancer Hospital and Research Centre  Muni Seva Ashram, Goraj - 391760,Waghodia, Vadodara, Gujarat, India
Vadodara
GUJARAT 		 9427423693

Vandanasetti.santhosh@greenashram.org 
Dr Priyal Dhameliya  Kiran hospital multi super speciality hospital and research center  Vasta Devdi Road, Near Sumul Dairy Road, Katargam, Surat, Gujarat 395004
Surat
GUJARAT 		 9428638448

drpriyalrsavaliya@gmail.com 
Dr Anil Kumar M R  Oncoville Cancer Hospital and Research Centre  No. 4, 80 Ft. Road, 7th Block, Nagarbhavi 2nd stage, Bangalore – 560072, Karnataka
Bangalore
KARNATAKA 		 9739808502

dranil.onco@gmail.com 
Dr Ghanshyam Biswas  Sparsh Hospital and Critical Care Private Limited  A 407, Saheed Nagar, Bhubaneshwar, Odisha 751007
Khordha
ORISSA 		 9937500878

drgbiswas@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
IEC Kailash Cancer Hospital and Research Centre  Approved 
Institutional Ethics Committee – HCG Curie CCC  Approved 
Institutional Ethics Committee HCG Cancer Centre  Approved 
Institutional Ethics Committee Oncoville Cancer Hospital and Research Centre  Approved 
Institutional Ethics Committee, Sparsh Hospitals and Critical Care Private Limited  Approved 
Kiran Hospital Ethics Committee,Kiran hospital multi super speciality hospital and research center, near Sumul dairy, Surat, Gujarat, India-395004  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C56||Malignant neoplasm of ovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LYNPARZA® (Olaparib) film-coated Tablets 150 mg   LYNPARZA® (Olaparib) film-coated Tablets 150 mg of AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Two tablets of 150 mg (300 mg) will be given twice daily for 6 days 
Intervention  Olaprib 150 mg tablets  Test product (T1): Olaparib film-coated Tablets 150 mg of Sun Pharmaceutical Industries Limited, India. Test product (T2): Olaparib film-coated Tablets 150 mg of Sun Pharmaceutical Industries Limited, India. Two tablets of 150 mg (300 mg) will be given twice daily for 6 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients fulfilling all the following inclusion criteria will be included in the study:
1. Male or female patients aged 18-75 years (both inclusive).
2. Patients who are willing and able to provide written informed consent prior to any study-related activities are performed.
3. Patients who are stable on olaparib 300 mg dose (150 mg x 2). Patients who are already taking and are stable on Olaparib 300 mg dose twice daily will enter into screening part I.
OR
Patients who are not stabilized on Olaparib will undergo screening part I and enter in stabilization period for 14 days followed by screening part II. This criteria will be evaluated after stabilization phase and at screening II.
4. Patients with documented diagnosis of either of following;
• Ovarian cancer:
Patients with deleterious or suspected deleterious germline or somatic BRCA mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
OR
Patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
OR
In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency positive status defined by either a) deleterious or suspected deleterious BRCA mutation, and/or b) genomic instability.
OR
• Breast cancer:
Patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
OR
Patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
OR
Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.

OR
• Prostate cancer:

Patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with abiraterone or enzalutamide.
OR
In combination abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

• Pancreatic cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

5. Patients who are able to swallow and retain oral medication.
6. Patients with Eastern Cooperative Oncology Group (ECOG) performance status of more than and equal to 2.
7. Patients with life expectancy of more than 90 days.
8. Patients with acceptable hematology and biochemistry status:
 Hemoglobin more than and equal to 8 g per dL
 Absolute neutrophil count more than and equal to 1500 cells per microliter
 Platelet count more than and equal to 1,00,000 cells per microliter
 Acceptable liver function:
• Alanine aminotransferase less than equal to 2 times upper limit of normal (ULN) (less than equal to 5 times ULN in case of liver metastasis)
• Aspartate aminotransferase less than equal to 2 times upper limit of normal (less than equal to 5 times ULN in case of liver metastasis) Bilirubin less than 1.5 mg per dL (less than 5 times ULN in case of liver metastasis)
• Alkaline phosphatase less than equal to 2 times upper limit of normal (less than equal to 5 times ULN in case of bone metastasis/prostate cancer)
9. Patients with creatinine clearance more than equal to 60 mL per minute calculated using Cockcroft-gault formaula.
10. Female patients with negative serum pregnancy test (to be performed at both screening part I and part II, as applicable)
11. Male patients with female partners of reproductive potential must agree to use condoms starting from screening, during study and for at least 03 months after treatment discontinuation.
12. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant) they must agree to use effective method of contraception during dosing and for at least 06 months after the treatment discontinuation) practicing two acceptable methods of contraception. Acceptable methods of contraception includes:
 Intrauterine device or intrauterine system
 Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
 Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) plus one additional contraception method (hormonal or barrier method)
 Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation
13. Female patients of non-childbearing potential or female patients who have completed menopause are defined as patients who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries.
14. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
15. 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 last sample collection in each study period.
16. Patients 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 last sample collection in each study period.
17. Patients willing to abstain from alcohol or alcoholic products at least 48.00 hours prior to first check-in until last sample collection in each study period.
 
 
ExclusionCriteria 
Details  Patients fulfilling any one of the following criteria will be excluded from the study:
1. Patients with known hypersensitivity to Olaparib or to any of the excipients of Test and Reference formulation.
2. Patients with Pneumonitis.
3. Patients currently using or in whom use of any of the prohibited medications is anticipated during study participation.
4. Patients who are breastfeeding and lactating.
5. Patients with known CNS metastasis.
6. Prostate cancer patients with history of venous thromboembolic events.
7. Patients with history of myelodysplastic syndrome or acute myeloid leukemia.
8. Patients who have ongoing grade 3-4 adverse event.
9. Patients with history of any 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).
10. Patients with any other medical condition or serious intercurrent illness (including cardiovascular, respiratory, metabolic and neurological disorders) that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study.
11. Any other condition(s) which could significantly interfere with protocol compliance.
12. Patients who have participated in any clinical study within 90 days before the first dose of Investigational Product (i.e., 90 days from last dose of previous study).
13. Patients with loss of more than euqal to 350 mL (1 unit) of blood within 90 days before entering into the study.
14. Patients with positive test for urine drugs of abuse and/or urine alcohol test on the day of every check-in.
15. Patients with history of alcohol dependence, alcohol abuse or drug abuse within past 6 months.
16. Patients who consumes grapefruit/ sweet lime (mosambi) juice within 48 hours prior to first check-in and for the entire period of study.
17. Patients receiving any medications that are strong inhibitors or inducers of the CYP3A enzyme and or any drugs known to interact with Olaparib prior to study or during the study.
18. Patients with positive serology for either Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency Virus.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary PK parameters: Cmax,ss and AUC0-Ï„,ss  at day 6 
 
Secondary Outcome  
Outcome  TimePoints 
Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd and Tmax,ss.  12 hours 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/04/2024 
Date of Study Completion (India) 01/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 comparative bioavailability study comparing olaparib 150 mg tablets of mg of Sun Pharmaceutical Industries Limited, India. to LYNPARZA® (Olaparib) film-coated Tablets 150 mg (2*150 mg Tablets) of AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 in patients with ovarian cancer or breast cancer or pancreatic adenocarcinoma or prostate cancer.

The study will be conducted at multiple investigator sites across India. Sufficient number of patients will be screened to randomize 24 patients in order to have 16 evaluable patients. Enrolment will continue until at least 16 patients complete all study periods. There are three periods in this study. Patients shall be randomized either test product 1 (T1) or test product 1 (T2) or reference product (R) for continuous 6 day dosing in period I. Patients will then be switched over to the other treatment (period II) based on randomization schedule for the next consecutive 6 days dosing and then swicthed over to other treatment (period III) for 6 days.

Total expected study duration will be approximately 68 days consisting of: Screening Part I: up to 21 days; Stabilization phase - minimum 14 days:  Screening Part II - up to 7 days: Patients who have undergone stabilization phase will enter into Screening Part II.; Treatment duration: 18 days; and Safety follow-up visit (telephonic): On Day 25 ± 2 days (i.e., 7 days after End of Treatment Assessment).

Patients who are already taking and are stable on Olaparib 300 mg dose twice daily will enter into screening part I. For such patients, stabilization period and screening part II will not be applicable.  Patients who are not stabilized on Olaparib will undergo screening part I (up to 21 days) and enter in stabilization period for 14 days followed by screening part II (up to 7 days). After confirmation of all inclusion & exclusion criteria, eligible patients will be randomized in the study. 
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