CTRI/2021/08/035525进行中（未招募）未知
A randomized, open label, multi-center, two-treatment, three period, three-sequence, reference replicate, multiple dose, steady-state, bioequivalence (BE) study of Olaparib Tablets 150 mg (2x150 mg tablets) of Natco Pharma Limited with LYNPARZA�® (Olaparib) tablets 150 mg (2x150 mg tablets) of AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, in male or female patients with ovarian cancer or breast cancer or prostate cancer. - NA
atco Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients will be considered eligible for the study based on the following criteria:
- •1. Willing and able to provide written informed consent prior to any study-related activities being performed.
- •2. 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 m2.
- •3. 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 platinum-based chemotherapy.
- •Patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
- •Patients with deleterious or suspected deleterious gBRCAm advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy
- •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. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
- •Patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.
- •4. Patients with established dosing regimen who are already receiving a stable dose of olaparib tablets (2x150 mg tablets) 300 mg twice daily.
- •5. Able to swallow and retain oral medication.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status Less than or equal to 2.
- •7. Life expectancy of Greater than 90 days.
- •8. Acceptable hematology status:
- •a. Hemoglobin Greater than or equal to 9 g per dL
- •b. Absolute neutrophil count (ANC) Greater than or equal to 1500 cells per microliter
- •c. Platelet count Greater than or equal to 1, 00,000 cells per microliter
- •9. Acceptable liver function:
- •a. Alanine aminotransferase Less than or equal to 2X upper limit of normal
- •b. Aspartate aminotransferase (AST) Less than or equal to 2X ULN
- •c. Bilirubin Less than 1.2 mg per dL
- •d. Alkaline phosphatase Less than or equal to 2X ULN
- •10. Patients with creatinine clearance Greater than or equal to 60 mL per minute.
- •11. Female patients with negative serum pregnancy test
- •12. Male patients with female partners of reproductive potential must agree to use condoms from screening, during study and for at least 03 months after treatment discontinuation.
- •13. 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 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 part
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •1. Known hypersensitivity to Olaparib or to any of the excipients.
- •2. Patients with Pneumonitis.
- •3. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •4. Current or anticipated use of any of the prohibited medications during study participation (Appendix B)
- •5. Patients who are breastfeeding and lactating.
- •6. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •7. Patients with Surgical or other non-healing wounds.
- •8. Known CNS metastasis.
- •9. 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.
- •10. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin Greather than or equal to9 g per dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], v5.0).
- •11. 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.
- •12. Patient tested positive for Coronavirus infection (COVID-19).
- •13. Any other condition(s) which could significantly interfere with Protocol compliance.
- •14. Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •15. Loss of Greather than or equal to350 mL (1 unit) of blood within 90 days of enrolment in the study.
- •16. Patients with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
研究者
相似试验
已完成
1 期
Comparative study of Nilutamide 150 mg tabletCTRI/2018/01/011386Genus Lifesciences Inc40
Unknown
不适用
euprorelin Acetate Injectable Suspension 11.25 mg in male subjects with metastatic prostate cancerCTRI/2019/08/020820Daewoong Pharmaceutical Co Ltd
进行中（未招募）
不适用
Bioequivalence study in advanced renal cell carcinoma patients under fasting condition.CTRI/2022/04/041694Oncogen Pharma Malaysia Sdn Bhd
已完成
4 期
Pharmacokinetic Study of Pazopanib in subjects with Advanced renal cell carcinoma.CTRI/2020/10/028441Torrent Pharmaceuticals Ltd India61
进行中（未招募）
不适用
Multiple dose, steady-state relative bioavailability of Pazopanib 200 mg tablets at a dose of 800 mg (4x200 mg tablets) in subjects with advanced renal cell carcinoma under fasting condition.CTRI/2021/04/032507Oncogen Pharma Malaysia Sdn Bhd15