CTRI/2025/05/086320 [Registered on: 05/05/2025] Trial Registered Prospectively
Last Modified On:
02/05/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Bioequivalence (BE) Study of Test Product Olaparib Tablets 150 mg (2 X 150 mg Tablets, twice daily) in Adult Participants with Cancer under Fasting Condition.
Scientific Title of Study
A Randomized, Open Label, Multi-Centre, Two-Treatment, Two-Period, Two-Sequence, Two-Way Cross-Over, Multiple-Dose, Steady-State, Bioequivalence (BE) Study of Test Product Olaparib Tablets 150 mg (2 X 150 mg Tablets, twice daily) of Win Medica S.A. with Lynparza (Olaparib) 150 mg Film-Coated Tablets (2 X 150 mg Tablets, twice daily) of AstraZeneca AB, SE-151 85 Sodertalje, Sweden in Adult Participants with Cancer under Fasting Condition.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No: C2A05114 Version: 01 Date: 25 Jan 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President Global Clinical Operation
Affiliation
Cliantha Research Ltd
Address
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9879590828
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director II - Clinical Trial Medical Services
Affiliation
Cliantha Research Ltd
Address
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
7966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Director - Clinical Trials
Affiliation
Cliantha Research Ltd
Address
Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
486, 2nd stanes road, 1st floor, Clinical Research room, Clinical research Department, Odakkadu, KNP Puram, Tiruppur - 641602, Tamil Nadu Coimbatore TAMIL NADU
9487018787
drrsk21@gmail.com
Dr K Velavan
Erode Cancer Centre
Room no 33, Ground floor, Department of radiation Oncology, 1/393, velavan nagar, Perundurai road, thindal, Erode 638012, Tamil Nadu, India Erode TAMIL NADU
9842334222
kvels@rediffmail.com
Dr Lakshmi Priyadarshini K
HCG City Cancer Center
2nd floor, Clinical research Department, Clinical Research room, 33-25-33, CH Venkata krishnayya street, Suryaraopet, Vijayawada-520002, Andhra Pradesh Krishna ANDHRA PRADESH
Clinical Research Department, Block A, Room no-A103, Swami Rama Himalayan University, Swami Rama Nagar, Jolly Grant, Deharadun - 248016, India Dehradun UTTARANCHAL
9411712969
drankitbatra@gmail.com
Dr Nilesh Ashok Dhamane
Kolhapur Cancer Centre PVT LTD
3rd floor, Clinical Research department, Clinical Trial Room, A/P R.S No. 238, opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur - 416234, Maharashtra, India Kolhapur MAHARASHTRA
7738245698
dr.nilesh.gmc@gmail.com
Dr Satish Sonawane
Maccare Superspeciality Hospital
Clinical Research department, Clinical Trial Room, Behind Zopadi Canteen, Opp. St Monica D.ed College, Savedi, Ahmednagar - 414003 Ahmadnagar MAHARASHTRA
9730099999
Satishujjwal@yahoo.com
Dr Anushree Chaturvedi
NIMS Heart and Brain Hospital
B28, B29, Govind Marg, Raja Park, Clinical Research room, Ground Floor, Clinical Research department, Jaipur, Rajasthan - 302004 Jaipur RAJASTHAN
9784076331
nhbh.clinical@gmail.com
Dr Jain Minish Mahendra
Prolife Cancer Centre and Research Institute
CRC Room, Clinical Research Department, 557A1, 15C, Jawaharlal Nehru Road, Burhanj Baug- B Colony, Market Yard, Gultekadi, Pune - 411037, Maharashtra Pune MAHARASHTRA
9823133390
Dr.minishjainprolifehospital@gmail.com
Dr Nirali Trivedi
Shankus Hospital Private Limited
Shankus Medicity 214/h Divine Child School, Near shankus Water Park, Basement, Clinical Research Room, Clinical Research department, Baliyasan, Mehsana - 382732, Gujarat Mahesana GUJARAT
Sujan Cancer & Surgical Hospital and Amravati Cancer Foundation
Room No.3, Clinical research room, 1st floor, Clinical Research department, 52/B, Shankar Nagar, Main Road, Amravati-444605, Maharashtra Amravati MAHARASHTRA
9823097573
rsaroradr@gmail.com
Dr Deepak Kumar Singh
Swami Harshankaranand Ji Hospital & Research Centre
Clinical Research department, Clinical Trial Room, N. 8/237, Newada, B.H.U-D.L. W Road, Newada, Sunderpur, Varanasi-221004, Uttar Pradesh, India Varanasi UTTAR PRADESH
9450428608
deepakbhu@gmail.com
Details of Ethics Committee
No of Ethics Committees= 16
Name of Committee
Approval Status
IEC Maharaja Agrasen Hospital
Approved
IEC, Bhandari Hospital and Research Center
Submittted/Under Review
AMRAVATI ETHICS COMMITTEE
Submittted/Under Review
Asha Hospitals Institutional Ethics Committee
Submittted/Under Review
BANKERS ETHICS COMMITTEE
Approved
Ethics Committee, Swami Rama Himalayan University
Submittted/Under Review
IEC Dr Mhaske Hospital and Research Centre
Submittted/Under Review
IEC Himalaya Cancer Hospital
Submittted/Under Review
IEC Shankus Hospitals
Submittted/Under Review
Institutional Ethics Commitee Maccare Hospital
Submittted/Under Review
Institutional Ethics Committee
Approved
INSTITUTIONAL ETHICS COMMITTEE - HCG Curie City Cancer Centre
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE ERODE CANCER CENTRE
Approved
INSTITUTIONNAL HUMAN ETHICS COMMITTEE
Approved
Kolhapur Cancer Centre (KCC) Institutional Ethics Committee
Submittted/Under Review
Shubham Sudbhawana Super. Hosp. Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C00-D49||Neoplasms,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Lynparza (Olaparib) 150 mg
Lynparza (Olaparib) 150 mg Film-Coated Tablets (two tablets) will be administered in the morning and evening, at an interval of at least 12 hours (± 60 minutes) between the doses, i.e., twice daily (total dose: 600 mg/day) as per the randomization schedule in treatment days (Day 01 to Day 14)
Intervention
Olaparib Tablets 150 mg
Olaparib Tablets 150 mg (two tablets) will be administered in the morning and evening, at an interval of at least 12 hours (± 60 minutes) between the doses, i.e., twice daily (total dose: 600 mg/day) as per the randomization schedule in treatment days (Day 01 to Day 14)
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Participant will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male or non-pregnant, non-lactating female between 18-65 years of age(both inclusive).
2. Participant with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/ or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who is in response (complete or partial) following completion of first-line platinum-based chemotherapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method.
OR Participant with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who is in response (complete or partial) to platinum-based chemotherapy. OR Monotherapy or in combination with endocrine therapy for the adjuvant
treatment of participant with germline BRCA1/2-mutations who has HER2-negative, high risk early breast cancer previously treated with
neoadjuvant or adjuvant chemotherapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with germline BRCA1/2-mutations, who has HER2 negative locally advanced or metastatic breast cancer. Participant should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless participants were not suitable for these treatments. Participants with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with germline BRCA1/2-mutations who has metastatic adenocarcinoma of the pancreas and has not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method. OR Participant with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who has progressed following prior therapy that included a new hormonal agent. Select participants based on a diagnostic test for BRCA mutation by NGS - Next Generation Sequencing method.
3. Participant with body mass index (BMI) 18.5-30.0 kg/m2 (both inclusive).
4. Participant with established dosing regimen who are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily for at least 15 days or willing to undergo at least 15 days of stabilization period with Olaparib tablets (2 x 150 mg tablets) 300 mg twice daily.
5. Participant with life expectancy greater than 90 days.
6. Acceptable hematology status at screening & prior to randomization:
a. Hemoglobin greater than or equals to 9 g/dL.
b. Absolute neutrophil count (ANC) greater than or equals to 1500 cells/microliter.
c. Platelet count greater than or equals to 1,00,000 cells/microliter.
d. WBC count greater than 3000/mm3
7. Acceptable liver function at screening & prior to randomization:
a. Alanine aminotransferase (ALT) less than or equals to 2.5 X Upper Limit Normal (ULN) (less than or equals to 5 X ULN for liver metastasis).
b. Aspartate aminotransferase (AST) less than or equals to 2.5 X ULN (less than or equals to 5 X ULN for liver metastasis)
c. Total bilirubin less than or equals to 1.5 X ULN. (less than or equals to 3 X ULN for liver metastasis)
d. Alkaline phosphatase less than or equals to 2X ULN.
8. Calculated serum creatinine clearance greater than or equals to 50 mL/min (using Cockcroft-Gault formula) which is as follows at screening & prior to randomization:
Formula of creatinine clearance: Crcl equals to (140 – Age) x mass (Kilogram weight) / 72 x S.Cr in (mg/dl), if ‘female’ x 85 percent.
9. Eastern Cooperative Oncology Group (ECOG) performance status less than or equals to 2.
10. Non-smokers and non-tobacco users (i.e., having no past history of smoking and tobacco consuming for at least one year prior to screening).
11. Male participant if sexually active with a female of child bearing potential must agree to use barrier method of contraception throughout the study period and for at least 6 months after last dose of study drug.
12. Female participant with postmenopausal status or female of child bearing potential with negative pregnancy test must agree to practice an acceptable method of contraception throughout the study period and for at least 6 months after last dose of study drug. Postmenopausal is defined by any one of the following:
a. Postmenopausal with spontaneous amenorrhea for at least one year, or.
b. 6 months to 12 months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU/mL.
c. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or.
d. Total hysterectomy and an absence of bleeding for at least 3 months.
13. Participant willing and able to comply with the protocol requirements
14. Participant/LAR willing to provide informed consent to participate in the study.
ExclusionCriteria
Details
Participant will not be eligible for inclusion in this study if any of the following criteria apply:
1. Participant with a known hypersensitivity to olaparib or any of the excipients of the product.
2. Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), radiotherapy within 4 weeks prior to stabilization.
3. Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization.
4. Participant with any ongoing toxicities [CTCAE (Common Terminology Criteria for Adverse Events) greater than or equals to grade 2], with the exception of alopecia, caused by previous cancer therapy.
5. Participant with known interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
6. Participant with known myelodysplastic syndrome/acute myeloid leukemia.
7. Participant with history/ risk of venous thromboembolic events.
8. Participant with symptomatic uncontrolled brain metastases. Participant can receive stable dose of steroids before and during study as long as these were started at least 4 weeks prior to treatment. Participant with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
9. Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery.
10. History of other malignancies in the last 5 years (Potential participants with prior history of in situ cancer or basal or squamous cell skin cancer are eligible).
11. Current or anticipated use of any prohibited medications during study participation.
12. Concomitant use of known strong or moderate CYP3A (Cytochrome P450 3A) inhibitors or inducer within 14 days before start of study medication/randomization.
13. Participant with serum positivity for Hepatitis B, C or HIV.
14. Participants with severe hepatic impairment (Child-Pugh classification C)
15. Any significant disease or condition which might compromise the haemopoeitic, gastrointestinal (e.g., pancreatitis), renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis, or any other body system.
16. Ingestion of any caffeine or xanthine products (i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), recreational drugs, dietary items that have effect on P450 enzymes (e.g., pomegranate, star fruit, seville oranges) & PGP (P-Glycoprotein) efflux pump (e.g., St. John’s wort) within 48 hours prior to randomization.
17. History of drug dependence, history of alcoholism [more than 2 drinks per day, 1 drink is defined as 360 mL of beer, 240 mL of malt liquor, 150 mL of wine and 45 mL of distilled spirits (gin, rum, vodka, whiskey, etc.)] in the past 1 years prior to screening.
18. Participant positive on alcohol urine analysis test at the time of baseline/randomization visit.
19. Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
20. Participation in any investigational drug study within 60 days prior to screening.
21. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
22. History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
23. Participant who are unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication.
24. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the participants participation in this study.
25. Any other condition or any clinically significant abnormalities in ECG or laboratory parameters that, in the investigators judgment, might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
26. Institutionalized participant
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Primary Endpoint(s): CmaxSS and AUC (0-tauSS)
2 Weeks
Secondary Outcome
Outcome
TimePoints
Additional Endpoint(s):
Ctauss, CminSS, CavSS, degree of fluctuation % [(CmaxSS-CminSS)/CavSS], swing [(CmaxSS-CminSS)/CminSS], and Tmax.
Safety endpoints: Incidence of Treatment-Emergent Adverse Events (TEAEs) and serious adverse events (SAE).
2 Weeks
Target Sample Size
Total Sample Size="52" Sample Size from India="52" 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)
24/05/2025
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)
Not Yet Recruiting
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
A
Randomized, Open Label, Multi-Centre, Two-Treatment, Two-Period, Two-Sequence,
Two-Way Cross-Over, Multiple-Dose, Steady-State, Bioequivalence (BE) Study of
Test Product Olaparib Tablets 150 mg (2 X 150 mg Tablets, twice daily) of Win
Medica S.A. with Lynparza (Olaparib) 150 mg Film-Coated Tablets (2 X 150 mg
Tablets, twice daily) of AstraZeneca AB, SE-151 85 Södertälje, Sweden in Adult
Participants with Cancer under Fasting Condition.