(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 39
- 主要终点
- Incidence of Adverse Events (AEs) and significant laboratory abnormalities
研究概览
简要总结
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
详细描述
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.
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
- •Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
- •Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
- •Able to dose orally
- •ECOG Performance status of 0-1
- •No other significant underlying ocular disease
- •Adequate organ function
- •Not pregnant/nursing or planning to become pregnant. Willing to use birth control
排除标准
- •Previous treatment with a Protein Kinase C (PKC) inhibitor
- •Concurrent malignant disease
- •Active HIV infection or Hep B/C
- •Malabsorption disorder
- •Unable to discontinue prohibited medication
- •Impaired cardiac function or clinically significant cardiac disease
- •Any other condition which may interfere with study interpretation or results
研究组 & 干预措施
darovasertib
IDE196 (darovasertib) oral open label
干预措施: Darovasertib (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) and significant laboratory abnormalities
时间窗: from first dose to 28 days after last dose of therapy, approximately 18 months
Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
时间窗: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
时间窗: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria
时间窗: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria
次要结局
- Evaluate tumor response to neoadjuvant IDE196(from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months)
- Assessment of visual acuity loss(from time of primary local therapy to one year after surgery, approximately 12 months)
- Rate of local disease recurrence(from date of primary local therapy to end of follow-up, approximately 36 months)
- Cohort 3 (patients with small UM tumors): Effect of neoadjuvant IDE196 therapy on the natural history of small UM tumors(from first dose of neoadjuvant to primary local therapy, approximately 12 months)
- Cohort 3 (patients with small UM tumors): Efficacy of neoadjuvant IDE196 therapy on small UM tumors(from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months)