NCT01115751已完成1 期
A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer
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
- 80
- 试验地点
- 1
- 主要终点
- Recommended dose for Phase 2 Studies
研究概览
简要总结
Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.
详细描述
JWAA will consist of the following treatment phases parts:
Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.
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
- •Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic (including Non-Hodgkin's Lymphoma). The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease.
- •Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.
- •Parts A and B: have measurable or nonmeasurable disease. Part C: have measurable disease.
- •Have adequate organ function, including:
- •Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 8 g/dL. Transfusions are not allowed to reach 8 g/dL prior to enrollment.
- •Hepatic: Bilirubin less than or equal to 1.5 times upper limits of normal (ULN), alanine aminotransaminase (ALT), and aspartate aminotransaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable.
- •Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance greater than 45 ml/mn.
- •Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Have discontinued previous treatments for cancer and recovered from the acute effects of therapy: at least 28 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents. At the discretion of the investigator, hormone-refractory prostate cancer patients who are stable on gonadotropin-releasing hormone (GnRH) agonist therapy may have that treatment continued while they are enrolled in this study.
排除标准
- •Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication.
- •Have serious preexisting medical conditions (left to the discretion of the investigator).
- •Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 60 days.
- •Have current acute or chronic leukemia.
- •Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- •Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results.
- •Have QTc interval of >470 msec on screening electrocardiogram(ECG).
- •Treatment with a strong CYP3A4 substrate with narrow therapeutic range, strong inhibitor, or inducer.
- •Have history of pituitary adenoma.
研究组 & 干预措施
LY2780301
Experimental
Part A: daily dosing
Part B (if determined as needed by pharmacokinetic, pharmacodynamic, and safety data): twice daily dosing
Part C: Dose and frequency as determined by Parts A and B of the study.
干预措施: LY2780301 (Drug)
结局指标
主要结局
Recommended dose for Phase 2 Studies
时间窗: Baseline to study completion
次要结局
- Clinically significant effects(Baseline to study completion)
- Pharmacokinetics, area under the concentration-time curve(Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2)
- Best overall response (CR+PR+SD)(Baseline to measured disease progression. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.)
- Progression-free survival(Baseline to measured disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.)
- Duration of response(Time of response to disease progression or death. Tumor assessments are performed every 2 cycles until disease progression and during post-study follow-up period.)
- Pharmacokinetics, maximum concentration (Cmax)(Baseline, Days 1, 2, 8, 15, and 22 of Cycle 1, Day 1 of Cycle 2)
研究者
研究点 (1)
Loading locations...
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