A Phase 1b Open Label, Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
研究概览
简要总结
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose levels. Vemurafenib has been approved by the United States Food and Drug Administration (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of unresectable or metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or female ≥18 years old.
- •Patients with histologically confirmed unresectable Stage III or Stage IV metastatic melanoma who have not been previously treated with a selective BRAF inhibitor.
- •Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation assay or comparable standard of care methodology.
- •Measurable disease per RECIST v. 1.1 criteria.
- •ECOG performance status 0 or 1.
排除标准
- •Radiation therapy within 14 days of C1D
- •Investigational drug use within 28 days of C1D
- •Patients with active CNS lesions are excluded (i.e., those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgery are eligible if they remain without evidence of disease progression in the brain for ≥3 weeks.
研究组 & 干预措施
Cohort 2
Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
干预措施: vemurafenib (Drug)
Dose extension cohort
Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts.
干预措施: PLX3397 (Drug)
Dose extension cohort
Patients will take PLX3397 and vemurafenib at the recommended phase 2 dose. This will be determined by the tolerability and safety of these drugs in the previous 3 cohorts.
干预措施: vemurafenib (Drug)
Cohort 3
Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
干预措施: PLX3397 (Drug)
Cohort 3
Patients will take 1000mg/day of PLX3397 and 960mg BID of vemurafenib
干预措施: vemurafenib (Drug)
Cohort 2
Patients will take 800mg/day of PLX3397 and 960mg BID of vemurafenib
干预措施: PLX3397 (Drug)
Cohort 1
Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
干预措施: PLX3397 (Drug)
Cohort 1
Patients will take 800mg/day of PLX3397 and 720mg BID of vemurafenib
干预措施: vemurafenib (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events Who Received PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
时间窗: 1 year
次要结局
未报告次要终点