NCT01106599已完成1 期
An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0623 Administered Daily in Patients With Locally Advanced or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.
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
- •Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
- •Evaluable disease or disease measurable per RECIST
- •Life expectancy >= 12 weeks
- •Adequate hematologic and end organ function
- •Agreement to use effective form of contraception for the duration of the study
- •Consent to provide archival tissue
- •For the cohort expansion stage (Stage II): Patients in this cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC [Stage IID])
排除标准
- •History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
- •History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
- •History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
- •Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
- •History of glaucoma
- •Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
- •Current severe, uncontrolled systemic disease
- •History of clinically significant cardiac dysfunction
- •History of active gastrointestinal bleeding within 6 months prior to screening
- •Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
- •Active autoimmune disease
- •Uncontrolled ascites
- •Pregnancy, lactation, or breastfeeding
- •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- •For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts
研究组 & 干预措施
A
Experimental
干预措施: GDC-0623 (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Through study completion or early discontinuation
Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0
时间窗: Through study completion or early discontinuation
Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life)
时间窗: Through study completion or early discontinuation
次要结局
- Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)(Through study completion or early discontinuation)
- Duration of objective response for patients with measurable disease according to RECIST(Through study completion or early discontinuation)
- Progression-free survival (PFS) for patients with measurable disease according to RECIST(Through study completion or early discontinuation)
研究者
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