CTRI/2026/01/100286招募中不适用
A randomized, open label, multi-centre, two-treatment, four-period, two-sequence, multiple dose, steady-state, full replicate, crossover, bioequivalence study of Olaparib tablets 150 mg (Sandoz Private Limited) and Lynparza tablets (Olaparib) 150 mg (AstraZeneca do Brasil Ltda) in participants with ovarian or breast or prostate cancer under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 8
研究概览
简要总结
This is a two-treatment, four-period, two-sequence, multiple dose, steady-state, full replicate, crossover, bioequivalence study of Olaparib tablets 150 mg in participants with ovarian or breast or prostate cancer under fasting condition.
Patients will be enrolled after providing written informed consent and treatments will be allocated to patient by carrying out randomization using statistical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with already diagnosed or known cases of.
- •Ovarian Cancer: Maintenance treatment of adult participants with ovarian carcinoma (including fallopian tube or primary peritoneal carcinoma), newly diagnosed, high-grade.
- •grade 2 or higher advanced, with BRCA mutation, who respond.
- •complete or partial response to first line, platinum based chemotherapy. OR Maintenance treatment of adult participants with serous ovarian carcinoma-including fallopian tube or primary peritoneal or endometrioid carcinoma, high grade.
- •grade 2 or higher, relapsed, platinum-sensitive and responsive.
- •complete or partial response to platinum-based chemotherapy. OR Breast Cancer: Adjuvant treatment of adult participants with HER2-negative high-risk early breast cancer with BRCA mutation, who were previously treated with neoadjuvant or adjuvant chemotherapy. OR Treatment of adult participants with HER2-negative, metastatic breast cancer with a germline mutation in BRCA gene.
- •pathogenic or suspected pathogenic previously treated with chemotherapy. These participants may have received chemotherapy in a neoadjuvant, adjuvant or metastatic setting. Participants with hormone receptor-positive breast cancer, must have been treated with prior endocrine therapy or be considered unsuitable for endocrine therapy. OR Prostate cancer: Monotherapy for the treatment of adult participants with metastatic castration-resistant prostate cancer and BRCA1/2 mutation involved in homologous recombination.
- •germline and/or somatic, whose disease progressed after prior treatment with a new hormonal agent.
- •Non-smoking, non-pregnant, non-lactating participant greater than or 18 years of age with a BMI in the range of 18.50 to 30.00 kg per m sqaure- both inclusive.
- •Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements.
- •Participant having an estimated survival of at least 3 months.
- •Eastern Cooperative Oncology Group performance status of 0-
- •Adequate organ and bone marrow function based upon the laboratory criteria at the time of eligibility assessment.
- •Absence of blood transfusion in the 28 days prior to randomization.
- •Women of non-child bearing potential with documented evidence of hysterectomy or bilateral oophorectomy at least 6 months prior to IMP administration or postmenopausal -defined as 12 consecutive months of spontaneous amenorrhea without medical explanation for at least one year. OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy.
- •oral, transdermal or implanted hormonal contraceptives in conjunction with a secondary method; non-hormonal intrauterine device + condom or diaphragm with spermicide; condom + diaphragm with spermicide; absolute sexual abstinence or sterile at least 6 months prior to IMP administration.
- •sexual partner for at least 4 weeks or 3 months for oral contraceptives prior to stabilization medication/IMP administration, during the study and for 6 months after the last dose of IMP.
- •Male participants must agree to not donate sperm and to use a condom when having sexual intercourse with a female partner who is pregnant or of child bearing potential from the first dose of stabilization medication or IMP, during the study and for 3 months after the last dose of IMP. Their female partners of child bearing potential should also use oral, transdermal or implanted hormonal contraceptives, non-hormonal intrauterine device, or diaphragm with spermicide.
排除标准
- •Participants who meet any of the following criteria at screening will not be enrolled in the study:
- •History of known hypersensitivity to Olaparib or its components which, in the opinion of the Investigator, would compromise the safety of the participant or the results of the study.
- •Participants found positive for HIV, Anti-HBc IgM, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •Have ongoing clinically significant adverse events due to prior treatments administered, as determined by the investigator.
- •Participants with Pneumonitis.
- •Participants with severe hepatic impairment.
- •Child Pugh classification category C, moderate renal impairment and severe renal impairment or end-stage renal disease.
- •In the opinion of the Investigator, the participant will not be compliant with the requirements of the study procedures.
- •Blood loss of 1 unit or 350 ml within 90 days prior to first dosing in Period I for the current study.
- •Usage of strong and moderate CYP3A inhibitors e.g., cimetidine, ciprofloxacin, grapefruit juice or strong and moderate CYP3A inducers e.g., carbamazepine, phenytoin, St. John’s Wort, rifampicin within 30 days prior to first dosing in Period I refer annexure XIII for full list of prohibited medications.
- •Pregnant or lactating females.
- •History or presence of alcoholism or drug abuse.
- •Difficulty in swallowing tablets.
研究者
Dr Rakesh Patel
Veeda Clinical research Limited
研究点 (8)
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