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.

Not yet recruiting

• Conditions: Neoplasms,

• Registration Number: CTRI/2025/05/086320
• Lead Sponsor: Win Medica S.A.

Brief Summary

ARandomized, Open Label, Multi-Centre, Two-Treatment, Two-Period, Two-Sequence,Two-Way Cross-Over, Multiple-Dose, Steady-State, Bioequivalence (BE) Study ofTest Product Olaparib Tablets 150 mg (2 X 150 mg Tablets, twice daily) of WinMedica S.A. with Lynparza (Olaparib) 150 mg Film-Coated Tablets (2 X 150 mgTablets, twice daily) of AstraZeneca AB, SE-151 85 Södertälje, Sweden in AdultParticipants with Cancer under Fasting Condition.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-02-05
• Study Start: 2025-05-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Participant receiving any systemic chemotherapy (except abiraterone or prednisone or prednisolone), radiotherapy within 4 weeks prior to stabilization.
• Participant who has or had drainage of ascites during the final 2 cycles of last chemotherapy regimen prior to randomization.
• 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.
• Participant with known interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
• Participant with known myelodysplastic syndrome/acute myeloid leukemia.
• Participant with history/ risk of venous thromboembolic events.
• 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.
• Major surgery within 2 months of screening or not recovered from any undesirable or harmful effects of any major surgery.
• 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).
• Current or anticipated use of any prohibited medications during study participation.
• Concomitant use of known strong or moderate CYP3A (Cytochrome P450 3A) inhibitors or inducer within 14 days before start of study medication/randomization.
• 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.
• 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.
• 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.
• Participant positive on alcohol urine analysis test at the time of baseline/randomization visit.
• Use of grapefruit and grapefruit containing products within 07 days prior to randomization.
• Participation in any investigational drug study within 60 days prior to screening.
• Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days.
• History of difficulty with donating blood or difficulty in accessibility of veins or intolerance to venipuncture.
• Participant who are unable to swallow orally administered medication and participant with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the participants participation in this study.
• 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.
• Institutionalized participant.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint(s): CmaxSS and AUC (0-tauSS)	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Additional Endpoint(s):	Ctauss, CminSS, CavSS, degree of fluctuation % [(CmaxSS-CminSS)/CavSS], swing [(CmaxSS-CminSS)/CminSS], and Tmax.

Trial Locations

Locations (16)

Asha Hospital and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Bankers Superspeciality Hospital; 🇮🇳 Vadodara, GUJARAT, India

Bhandari Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Deepa Hospital (Indian Cancer Center); 🇮🇳 Coimbatore, TAMIL NADU, India

Erode Cancer Centre; 🇮🇳 Erode, TAMIL NADU, India

HCG City Cancer Center; 🇮🇳 Krishna, ANDHRA PRADESH, India

Himalaya Cancer Hospital and Research Institute; 🇮🇳 Vadodara, GUJARAT, India

Himalaya Institute of Medical Sciences; 🇮🇳 Dehradun, UTTARANCHAL, India

Kolhapur Cancer Centre PVT LTD; 🇮🇳 Kolhapur, MAHARASHTRA, India

Maccare Superspeciality Hospital; 🇮🇳 Ahmadnagar, MAHARASHTRA, India

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Asha Hospital and Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Rajeev L K

Principal investigator

7022247227

drrajeevvlk@gmail.com