CTRI/2024/09/074142进行中（未招募）不适用
A Randomized, Open-label, Multi-center, Balanced, Three-period, Three-sequence, Three-way cross-over, Steady-state, Bioequivalence, Comparative Study of Niraparib 200mg Tablets of Sun Pharmaceutical Industries Limited with ZEJULA (Niraparib) 200mg Tablets of GlaxoSmithKline, Durham, NC and ZEJULA (Niraparib) 100mg Tablets (2 x 100mg tablet) of GlaxoSmithKline, Ireland, in First-Line Maintenance Treatment of Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer patients under Fasting Conditions.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 23
- 主要终点
- Cmax,ss, AUC0-Ï„
研究概览
简要总结
This is a Randomized, Open-label, Multi-center, Balanced, Three-period, Three-sequence, Three-way cross-over, Pharmacokinetic endpoint, Steady-state Bioequivalence study. The study is planned to randomize 72 patients of Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer patients. The primary objective is evaluate the bioequivalence of the Test Product i.e., Niraparib tablets 200mg of Sun Pharmaceutical Industries Limited., India in comparison with the Reference Products, ZEJULA (Niraparib) tablets of GlaxoSmithKline. The secondary objective is to monitor the safety and tolerability of the patients during the study.
The study will be conducted in multiple clinical centers in India wherein sufficient patients will be screened to randomize 72 patients to have 54 evaluable patients’ data for the statistical analysis. Additional patients may be recruited in case the number of 54 evaluable patients is not achieved due to dropout/withdrawals, after agreement with the Sponsor.
The total expected study duration will be approximately 58 days consisting of Screening Part I: Up to 07 days; Stabilization Phase: At least 07 days. Patients who meet the screening requirement will be stabilized on Niraparib with a dosage regimen of Niraparib 200 mg once daily. This will be followed by a screening Part II - Up to 07 days wherein Patients who have undergone the stabilization phase will enter Screening Part II. The treatment Period is of 36 days (Period-I: Day 1 to 12; Period-II: Day 13 to 24, Period-III: Day 25 to 36). The end of Treatment Assessment will be done on on Day 37 after the last PK sample collection
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
- Female
入选标准
- •Female patients of 18 to 75 years (both inclusive) at the time of signing the informed consent form.
- •Patients with documented advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
- •Patients must have received their most recent platinum-containing regimen within 12 weeks prior to initiating Niraparib treatment.
- •Patients with weight of less than 77 Kg (less than 170 lbs) or with a platelet count less than 150,000/μL at the time of screening.
- •Patients with Eastern Cooperation Oncology Group (ECOG) performance status of 0-2 at screening
- •ïƒ˜ Absolute neutrophil count more than equal to 1500 per µL  Platelets count more than equal to 100,000 per µL  Haemoglobin more than equal to 9 g per dL  Serum creatinine less than equal to 1.5 × ULN  Serum total bilirubin less than equal to 1.5 × ULN  Serum aspartate aminotransferase and alanine aminotransferase more than equal to 2.5 × ULN; more than equal to 5 × ULN in patients with liver infiltration
- •Patients with a negative test for Human Immunodeficiency Virus type I/II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies at screening.
- •Patients of childbearing age (defined as women physiologically capable of becoming pregnant) who agree to use effective contraception and not to donate eggs starting from the date of signing the informed consent form and for at least 6 months after the last dose of Niraparib.
- •Acceptable methods of contraception include:  Intrauterine device or intrauterine system  Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)  Hormonal contraception  Female sterilization (surgical bilateral oophorectomy) or tubal ligation within at least 6 weeks prior to study participation  Male sterilization (at least 6 months prior to the screening, should be the sole male partner for that patient) plus one additional contraception method.
- •Female patients of non-childbearing potential or female patients who have attained or achieved menopause which is defined as females with consecutive 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries.
- •Non-lactating patients
- •Patients of childbearing potential with a negative serum pregnancy test at Screening Part I and II, a negative urine pregnancy test at baseline/randomization visit (Day 0) and on the day of check-in of all the periods.
- •Patients with a life expectancy of more than 90 days.
- •Patients with no history of addiction to any recreational drug or drug dependence or alcohol addiction.
- •Patients who are preferably non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco-containing products at least 48.00 hours prior to first check-in until the last sample collection in each study period.
- •Patients who are 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 the last sample collection in each study period.
- •Patients who are willing to abstain from alcohol or alcoholic products at least 48.00 hours prior to first check-in until the last sample collection in each study period.
- •Patients who are willing to be available for the entire study period and to comply with the protocol requirements.
排除标准
- •Patient with contraindications or hypersensitivity to Niraparib or related other PARP-1 and PARP-2 {Poly (ADP-ribose) polymerase} inhibitors such as Olaparib, Rucaparib etc.
- •Patients with a history of persistent toxicity (more than grade 2) from prior cancer therapy.
- •If patients require dose modification (other than Niraparib 200 mg daily dose) or with expected changes in concomitant medications.
- •Patients who have received palliative radiotherapy within 1 week of screening (encompassing more than 20% of the bone marrow).
- •Patients with known symptomatic, uncontrolled brain or leptomeningeal metastases.
- •Patients who have undergone any major surgery within 3 weeks before initiation of the study.
- •Patients who are receiving prohibited medications such as Anti-coagulants or drugs that reduce thrombocyte counts during the study period.
- •Patients with an active or history of cerebrovascular diseases, such as stroke, or cerebral hemorrhage within 6 months before the screening.
- •Patients who are unable to swallow orally administered drugs; or have gastric, gastro-esophageal, or esophageal cancer or any other gastrointestinal-related disorders that are likely to interfere with the absorption of investigational products.
- •Patients with a history of myelodysplastic syndrome or acute myeloid leukemia.
- •Patients who are pregnant, breastfeeding, or planning to become pregnant during this study period.
- •Patients with psychiatric or neurological disorders.
- •Patients with positive tests for urine drugs of abuse and alcohol breath test on the day of Screening Part I, Randomization Day and every check-in day.
- •Patients who consume grapefruit within 48 hours prior to first check-in and for the entire period of study.
- •Ingestion of any alcoholic beverage within the 48 hours prior to first check-in until the last PK sample collection in each study period.
- •Patients who have donated/lost blood (more than 350 ml/1 unit) in the past 3 months before screening.
- •Patients with any condition for which, in the opinion of the investigator, it would not be in the best interest of the patient and may compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
Cmax,ss, AUC0-Ï„
时间窗: Day 36
次要结局
- 1. PK endpoints: Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd,, Tmax,ss(2. Safety endpoint: Incidence of TEAEs (Treatment-Emergent Adverse Events))
研究者
Dr Kanchan Tyagi
Sun Pharmaceutical Industries Limited
研究点 (23)
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