CTRI/2026/02/104311尚未招募不适用
A Randomized, Assessor Blind, Three-Treatment, Three-Period, Three-Sequence, Balanced, Multiple-Dose, Multi-Center, Crossover Study to Assess Bioequivalence of Olaparib Tablets of Intas Pharmaceuticals Limited Compared with Lynparza in Participants with Solid Tumours Under Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 5
研究概览
简要总结
This is a study to assess Bioequivalence of Olaparib Tablets in Participants with Cancer Under Fasting Condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study.
- •Man or woman participant must be at least 18 years of age, at the time of signing the informed consent.
- •Body mass index (BMI) within the range 18.5 to 30 kg per m2 (inclusive).
- •Participants with following disease who are eligible to received olaparib monotherapy: Maintenance treatment advanced [International Federation of Gynecology and Obstetrics (FIGO) stages III and IV] BRCA1 2-mutated (germline and or somatic) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy OR Maintenance treatment of platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; OR Adjuvant treatment of Participants with germline BRCA1 2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy; OR Participants with germline BRCA1 2-mutations, who have HER2 negative locally advanced or metastatic breast cancer.
- •Participants 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; OR Maintenance treatment of adult Participants with germline BRCA1 2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
- •OR Treatment of adult Participants with metastatic castration-resistant prostate cancer and BRCA1 2-mutations (germline and or somatic) who have progressed following prior therapy that included a new hormonal agent.
- •Note: Documented mutation in germline/somatic BRCA1/2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental lead to loss of function) can be assessed from any previous test report available for the participant.
- •If documented BRCA1 2 test results are not available, then participants will be required to undergo BRCA1 2 testing.
- •Participants with established dosing regimen for at least 14 days who already are receiving a stable dose of olaparib tablet (2 into 150 mg tablets) 300 mg twice daily.
- •OR Participants not stabilized on olaparib olaparib treatment naïve participants who are eligible to take olaparib tablet (2 into 150 mg tablets) 300 mg twice daily for dose stabilization and are prescribed Olaparib monotherapy as per the independent judgement of PI as per local practices.
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 at screening.
- •(ECOG PS 2 will be allowed only if it is due to disease indication and not due to comorbidities) 7) Participant has recovered from adverse events (baseline or less than or equal to CTCAE Grade 1) due to prior anti-cancer therapy, unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator.
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in 10.4.
- •Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percent per year), with low user dependency when used consistently and correctly, as described in Appendix 4: Contraceptive and Barrier Guidance during the stabilization phase (if applicable), during the intervention phase and for at least 6 months after the last dose of study intervention and agrees not to donate eggs ova, oocytes) for the purpose of reproduction during the stabilization phase (if applicable), during the intervention phase and for at least 6 months after the last dose of study intervention.
- •The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive serum pregnancy at screening; and urine pregnancy test within 24 hours before the first dose of investigational intervention.
- •If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required.
- •In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- •Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.
- •The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Male participants are eligible to participate if they agree to the following during the stabilization phase (if applicable), during the intervention phase and for at least 3 months after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for the purpose of reproduction PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use contraception barrier as detailed below a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person with female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percent per year as described in Appendix
- •Participant with adequate hematologic, liver and renal function at screening visit: a) ANC greater than or equal to 1500 per cu.mm.
- •b) Platelet count greater than or equal to 100,000 per cu.mm (At screening assessment, criteria must be met without platelet transfusion within prior 1 week).
- •c) Haemoglobin greater than or equal to 9.0 g per dL (At screening assessment, criteria must be met without erythropoietin stimulating agent dependency and without packed red blood cell (pRBC) or whole blood transfusion within prior 1 week) d) Estimated Creatinine clearance of greater than 50 mL per min by the Cockcroft-Gault formula.
- •e) Alanine transaminase (ALT) and AST less than or equal to 2.5 into upper limit of normal (ULN) (less than or equal to 5 into ULN for liver metastasis) f) Total bilirubin less than or equal to 1.5 into ULN.
- •Participants who are able to swallow and retain oral medication.
排除标准
- •Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components excipients thereof (refer to the SmPC1 and Health Canada Product Monograph) or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- •Had major surgical procedure within 4 weeks before screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study.
- •NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator.
- •History or current evidence of pneumonitis or Venous Thromboembolic Events (VTE) as assessed by the investigator clinically or radiologically from the most recent scans.
- •Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of investigational intervention.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.
- •NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.
- •Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
- •History of drug or alcohol abuse within 1 year prior to screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at baseline.
- •History of malignancy except cancer under study within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
- •Note: The time requirement for no evidence of disease for at least 3 years does not apply to the cancer under study for which a participant is enrolled in the study.
- •The time requirement also does not apply to participants basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers who underwent successful definitive resection with no evidence of metastatic disease which is considered cured with minimal risk of recurrence.
- •Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the study.
- •Past or intended use of any disallowed therapies as noted in Section 6.9, Prior and Concomitant Therapy 12) Participants who require dosage modification or with expected changes in concomitant medications that may potentially affect the pharmacokinetics of olaparib during the study.
- •Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer, or is currently enrolled in an investigational study.
- •Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the investigational intervention).
- •Donated blood or blood products or had substantial loss of blood (more than 350 mL) within 3 months before the first dose of study intervention or intention to donate blood or blood products during the study.
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (5)
Loading locations...
相似试验
尚未招募
不适用
Bioequivalence Study of Olaparib Tablets 150 mg under Fasting Condition.CTRI/2025/11/097436Alembic Pharmaceuticals Limited42
进行中（未招募）
不适用
BE study of Olaparib Tablets 150 mg (2x150 mg tablets) with Lynparza® 150mg Filmtabletten Olaparib (2x150 mg tablets) in adult patients with carcinoma of the ovary, breast, prostate or adenocarcinoma of the pancreas.CTRI/2024/10/074806Alembic Pharmaceuticals Limited42
已完成
不适用
To assess bioequivalence between Olaparib tablets, 150mg and LYNPARZA 150mg Olaparib tablets of AstraZeneca AB, SwedenCTRI/2024/09/073709AET Laboratories Private Limited42
已完成
不适用
To assess bioequivalence between Olaparib tablets, 150mg and LYNPARZA® 150mg Olaparib tablets of AstraZeneca AB, SwedenCTRI/2024/09/073656AET Laboratories Private Limited42
招募中
2 期
Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.A Belgian Precision 2 study2024-518522-32-00Belgian Society Of Medical Oncology351