An Open Label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors
研究概览
简要总结
The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL participants treated with MK-3795.
详细描述
This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of MK-3795 in participants with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). MK-3795 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems
- •Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
排除标准
- •Has had prior radiotherapy or systemic anti cancer therapy for ccRCC (includes anti-VEGF therapy or any systemic investigational anti cancer agent)
- •Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the participant has remained disease free for more than 2 years
- •Has any history of metastatic disease
- •Has had radiotherapy to any non-ccRCC site within 4 weeks prior to entering the study or has not recovered from adverse events (AE)
- •Has had any surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed
研究组 & 干预措施
MK-3795
Participants receive 800 mg MK-3795 orally twice daily. Participants may continue to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
干预措施: MK-3795 (Drug)
结局指标
主要结局
Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors
时间窗: Up to approximately 76 months
ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis.
次要结局
- Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors(Up to approximately 76 months)
- Duration of Response (DOR) in VHL Disease-Associated ccRCC Tumors(Up to approximately 76 months)
- Time to Response (TTR) in VHL Disease-Associated ccRCC Tumors(Up to approximately 76 months)
- Overall Response Rate (ORR) in VHL Disease-Associated Non-ccRCC Tumors(Up to approximately 76 months)
- Progression-free Survival (PFS) in VHL Disease-Associated Non-ccRCC Tumors(Up to approximately 76 months)
- Duration of Response (DOR) in VHL Disease-Associated Non-ccRCC Tumors(Up to approximately 76 months)
- Time to Response (TTR) in VHL Disease-Associated Non-ccRCC Tumors(Up to approximately 76 months)
- MK-3795 Plasma Concentration(Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose)
- MK-3795 Metabolite Plasma Concentration(Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose)
- Number of Participants Who Experienced One or More Adverse Events (AEs)(Up to approximately 76 months)
- Number of Participants Who Discontinued Study Intervention Due to an AE(Up to approximately 74 months)