CTRI/2025/07/091607尚未招募不适用
A randomized, open label, multi-center, two-treatment, two-period, two-sequence, fully replicate, cross-over, multiple dose, steady-state, bioequivalence study of Olaparib Tablets 150 mg (2x150 mg tablets) of Qilu Pharmaceutical (Hainan) Co., Ltd. with Lynparza® 150 mg Film-coated tablets (Olaparib (2x150 mg tablets)) of AstraZeneca AB, Sweden, in adult patients with carcinoma of the ovary, breast, prostate or adenocarcinoma of the pancreas under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- To compare the bioavailability and characterize the pharmacokinetic profiles of Olaparib tablets 150 mg (2x150 mg tablets) of Qilu Pharmaceutical (Hainan) Co., Ltd. with Lynparza® 150 mg Film-coated tablets (Olaparib (2x150 mg tablets)) of AstraZeneca AB, Sweden at steady state and to assess the bioequivalence under fasting condition.
研究概览
简要总结
The study is a randomized, open label, multi-center, two-treatment, two-period, two-sequence, fully replicate, cross-over, multiple dose, steady-state, bioequivalence study of Olaparib Tablets 150 mg (2*150 mg tablets) of Qilu Pharmaceutical (Hainan) Co., Ltd. with Lynparza® 150 mg Film-coated tablets [Olaparib (2*150 mg tablets)] of AstraZeneca AB, Sweden, in adult patients with carcinoma of the ovary, breast, prostate or adenocarcinoma of the pancreas under fasting condition, the study assesses the pharmacokinetic profiles of the two formulations at steady-state to determine if they can be considered equivalent in terms of their absorption and overall bioavailability.
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
- •Patients will be considered eligible for the study based on the following criteria:
- •Willing and able to provide written informed consent prior to any study-related activities being performed.
- •Male or female patients aged 18 years and older and having Body mass index (BMI) greater than or equal to 17 calculated as weight in kg per height in m
- •Patients who are non-smokers and non-tobacco users (ie.
- •having no past history of smoking and tobacco consumption for at least one year prior to screening).
- •Patients who require treatment with the study drug as monotherapy.
- •Patients with documented advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
- •OR Patients with documented platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Patient will start treatment with Olaparib no later than 8 weeks or as per PI discretion based on local standard of care after completion of their final dose of the platinum-containing regimen).
- •OR Patients with documented germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
- •OR Patients with documented germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer.
- •Patients who have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients are not suitable for these treatments.
- •Patients with hormone receptor (HR)-positive breast cancer who have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
- •OR Patients with documented 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.
- •OR Patients with documented 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.
- •Patients with established and well tolerated dosing regimen, who are already receiving a stable dose of Olaparib tablets (2x150 mg tablets) 300 mg twice daily for at least 15 days.
- •Note: For patients who will enter stabilization period, this criteria will be evaluated on the day of randomization.
- •Able to swallow and retain oral medication.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
- •The life expectancy of greater than 90 days.
- •Acceptable hematology status: a.
- •Hemoglobin greater than or equal to 9 G percent (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) b.
- •Absolute neutrophil count (ANC) greater than or equal to 1500 cells per micro L c.
- •Absolute white blood cell (WBC) count greater than or equal to 3000 cells per micro L d.
- •Acceptable liver function: a.
- •Alanine aminotransferase less than or equal to 2X upper limit of normal (ULN) Note: For patients with liver metastasis: Alanine aminotransferase less than 5X ULN b.
- •Aspartate aminotransferase less than or equal to 2X ULN Note: For patients with liver metastasis: Aspartate aminotransferase less than 5X ULN c.
- •Bilirubin less than 1.5 X ULN d.
- •Alkaline phosphatase less than or equal to 2X ULN Note: For patients with Hepatic or bone metastasis: Alkaline phosphatase less than 5X ULN
- •Female patients of child bearing potential with a negative serum pregnancy test at the time of screening.
- •Male patients with female partners of reproductive potential must agree to use barrier contraceptives (condom) from screening, during study and for at least 03 months after treatment discontinuation.
- •Female partners of male patients must also use acceptable method of contraception for the same duration mentioned for male patients above if they are of childbearing potential.
- •Women of childbearing potential, (defined as women physiologically capable of becoming pregnant) must agree to use two highly effective and complementary methods of contraception during study participation and for at least 06 months after the treatment discontinuation.
- •Acceptable methods of contraception are: a.
- •Intrauterine device or intrauterine system b.
- •Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent) c.
- •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) d.
- •Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation e.
- •Total abstinence, partial abstinence is not acceptable.
- •Female patients of non-childbearing potential or female patients who have completed menopause are defined as patients who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries.
- •Female patients of non-childbearing potential are not required to use effective method of contraception during the study.
- •No history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •Patients who agree not to drive or operate heavy machinery if feeling dizzy or drowsy or fatigue following study drug administration until full mental alertness is regained.
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •Known hypersensitivity to Olaparib or to any of the excipients.
- •Patients with known cases of pneumonitis.
- •Patients with known cases of myleodysplastic syndrome and acute myeloid leukemia.
- •Presence of any uncontrolled systemic disease (eg.
- •cardiovascular disease, hypertension, diabetes mellitus etc.) within last 6 months prior to screening.
- •Current or anticipated use of any of the prohibited medications during study participation (Appendix B)
- •Patients who are breastfeeding or lactating
- •Patients having undergone major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •Patients with known CNS metastasis.
- •Patients with history of Venous thromboembolic events within 2 months prior to screening.
- •Patients with history of 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 who have administered any live vaccine (measles or mumps or rubella (MMR) or varicella (chickenpox) or rotavirus or yellow fever or BCG (Bacillus Calmette-Guérin) etc.) within 28 days before the first dose of Investigational Product.
- •Patients who have not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents.
- •Exceptions are alopecia (any grade is acceptable), Hemoglobin greater than or equal to 9 G percent, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), v5.0).
- •Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study.
- •Any other condition(s) which could significantly interfere with protocol compliance.
- •Use of grapefruit or grapefruit products, seville oranges and its juice and recreational drugs within 72 hours prior to IP administration on Day
- •Ingestion of any caffeine or xanthine containing food or beverages (tea, coffee, chocolates or cola drinks) within 48 hours prior to IP administration on Day
- •Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •Loss of greater than or equal to 350 mL (1 unit) of blood within 90 days of enrolment in the study.
- •Patients with positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Note: Patients with Hepatitis B core antibody (HBcAb) positive result, can be enrolled if a confirmatory negative test is obtained suggestive of no active infection currently.
结局指标
主要结局
To compare the bioavailability and characterize the pharmacokinetic profiles of Olaparib tablets 150 mg (2x150 mg tablets) of Qilu Pharmaceutical (Hainan) Co., Ltd. with Lynparza® 150 mg Film-coated tablets (Olaparib (2x150 mg tablets)) of AstraZeneca AB, Sweden at steady state and to assess the bioequivalence under fasting condition.
时间窗: Day 5,6,13,14 (Pre Dose), Day 7, 8, 15, 16 (Pre Dose 00.00 Hrs, Post Dose - 00.25 Hrs, 00.50 Hrs, 01.00 Hrs, 01.25 Hrs, 01.50 Hrs, 01.75 Hrs, 02.00 Hrs, 02.33 Hrs, 02.67 Hrs, 03.00 Hrs, 03.50 Hrs, 04.00 Hrs, 06.00 Hrs, 08.00 Hrs, 12.00 Hrs)
次要结局
- To monitor the safety of the patients.(A total of Thirty-Four (34) blood samples of 03.0 mL each will be collected for PK analysis in each period of the study. A total of 68 blood samples will be collected during the study.)
研究者
研究点 (11)
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