A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Relugolix Tablets for the Treatment of Advanced Prostate Cancer
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Sun Pharmaceutical Industries Limited (SPIL)
- 入组人数
- 127
- 试验地点
- 4
- 主要终点
- 1. Sustained castration rate defined as proportion of patients achieving and maintaining serum testosterone at castrate level (lesser than 50ng/dL) by week 4 through 24 weeks of treatment
概览
简要总结
This is a Phase IV, single arm, multicenter, open label, study in patients with advanced prostate cancer. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.
After confirming the eligibility patients will be enrolled in the study. The enrolled patients will undergo 24 weeks treatment period. Patients will receive a loading dose of 360 mg (3 tablets of Relugolix 120 mg) on day 1. From day 2, patients will take 1 tablet of Relugolix 120 mg daily till day 169 for 24 weeks (Treatment period). And week 24 will be considered EOT visit. During the study, assessments will be performed as mentioned in Schedule of Assessment.
The study consists of total twelve visits. Both efficacy and safety will be assessed during the study period. Patients who are withdrawn/ terminating early from the study will complete end of treatment visit assessment and will be followed up for safety 2 weeks after last IP dose. Patients will be provided with diary to record details about study drug administration and adverse events. Patients will be required to bring completed diary of previous visit at upcoming visit to facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patient will be included if all the inclusion criteria listed below are met:
- •Male patients aged greater than or equal to 18 years who agree to provide written informed consent
- •Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- •Patient is a candidate for, in the opinion of the investigator, at least 6 months of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer
- •Has a serum testosterone at the Screening and randomization visit of greater than or equal to 150 ng/dL
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline
- •Is a male patient who, even if surgically sterilized, agrees to use a male condom if having sex with a woman of childbearing potential or a pregnant woman, during the entire study Treatment Period and for at least 2 weeks after last treatment dose.
排除标准
- •Patient will be excluded if any disease specific or study specific exclusion criteria listed below are met:
- •In the investigators opinion, is likely to require chemotherapy or surgical therapy for disease management within 6 months of initiating study drug
- •Previously received gonadotropin-releasing hormone analogue or other form of androgen deprivation therapy (estrogen or antiandrogen) for greater than 18 months total duration.
- •If androgen deprivation therapy was received for lesser than or equal to 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline.
- •If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot
- •Previous systemic cytotoxic treatment for prostate cancer
- •Patients with suspected Brain metastasis based on clinical evaluation
- •History of surgical castration
- •Have following laboratory values at screening • Serum ALT and/or AST greater than 2 ULN • Total bilirubin greater than ULN • Serum creatinine greater than 2.0 mg/dL • Platelets less than 100 x 1000 /µL • Hemoglobin less than 10.0 g/dL • Leukocytes (WBC) less than 3 x 1000 /µL • Absolute neutrophil count less than 1.5 x 1000/µL
- •Previous treatment with Relugolix.
结局指标
主要结局
1. Sustained castration rate defined as proportion of patients achieving and maintaining serum testosterone at castrate level (lesser than 50ng/dL) by week 4 through 24 weeks of treatment
时间窗: Day 29 to Day 169
次要结局
- 1. Castration rate defined as proportion of patients achieving serum testosterone lesser than 50ng/dL.(Day 4, Day 8 (week 1) and Day 15 (week 2))
- 2. Profound castration rate defined as proportion of patients achieving serum testosterone lesser than 20ng/dL(Day 15 (week 2))
- 3. Sustained Profound castration rate defined as proportion of patients achieving and maintaining serum testosterone suppression of lesser than 20 ng/dL by Week 4 through 24 weeks of treatment([Day 29 to Day 169].)
- 4. PSA response rate(Day 15 (week 2), Day 29 (week 4), Day 57 (week 8), Day 85 (week 12), Day 113 (week 16), Day 141 (week 20), Day 169 (week 24))
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited