CTRI/2024/04/065314已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Primary PK parameters: Cmax,ss and AUC0-Ï„,ss
研究概览
简要总结
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.
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 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling all the following inclusion criteria will be included in the study:
- •Male or female patients aged 18-75 years (both inclusive).
- •Patients who are willing and able to provide written informed consent prior to any study-related activities are performed.
- •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.
- •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.
- •â€¢ 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.
- •Patients who are able to swallow and retain oral medication.
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status of more than and equal to
- •Patients with life expectancy of more than 90 days.
- •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)
- •Patients with creatinine clearance more than equal to 60 mL per minute calculated using Cockcroft-gault formaula.
- •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.
- •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
- •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.
- •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.
排除标准
- •Patients fulfilling any one of the following criteria will be excluded from the study:
- •Patients with known hypersensitivity to Olaparib or to any of the excipients of Test and Reference formulation.
- •Patients with Pneumonitis.
- •Patients currently using or in whom use of any of the prohibited medications is anticipated during study participation.
- •Patients who are breastfeeding and lactating.
- •Patients with known CNS metastasis.
- •Prostate cancer patients with history of venous thromboembolic events.
- •Patients with history of myelodysplastic syndrome or acute myeloid leukemia.
- •Patients who have ongoing grade 3-4 adverse event.
- •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).
- •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.
- •Any other condition(s) which could significantly interfere with protocol compliance.
- •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).
- •Patients with loss of more than euqal to 350 mL (1 unit) of blood within 90 days before entering into the study.
- •Patients with positive test for urine drugs of abuse and/or urine alcohol test on the day of every check-in.
- •Patients with history of alcohol dependence, alcohol abuse or drug abuse within past 6 months.
- •Patients who consumes grapefruit/ sweet lime (mosambi) juice within 48 hours prior to first check-in and for the entire period of study.
- •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.
结局指标
主要结局
Primary PK parameters: Cmax,ss and AUC0-Ï„,ss
时间窗: at day 6
次要结局
- Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd and Tmax,ss.(12 hours)
研究者
Dr Kanchan Tyagi
Sun Pharmaceutical Industries Limited
研究点 (6)
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