NCT00514007已完成1 期
A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced 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
- 95
- 试验地点
- 2
- 主要终点
- Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906
研究概览
简要总结
Multicenter, open-label, phase 1, cohort dose escalation study to determine the Maximum Tolerated Dose (MTD) on both Once Daily (QD) and Twice Daily (BID) schedules.
详细描述
Multicenter, open-label, phase 1, cohort dose escalation.
The study will open with the QD schedule, with initiation of the BID schedule occurring after observation of clinically significant related toxicity ≥ grade 2 in the QD schedule.
Dosing will be initiated on Day 1 with daily dosing (either QD or BID) continuing for 21 days.
Once the recommended phase 2 dose has been determined for the BID schedule, 2 expansion cohorts will be opened: 1) Biomarker Expansion Cohort in patients with locally advanced or metastatic colorectal cancer and 2) Diabetic Expansion Cohort in patients with advanced solid tumors who have active Type 2 diabetes mellitus not requiring insulin or insulinotropic therapy.
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 malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists. Patients in the Biomarker Expansion Cohort must have histologically documented colorectal cancer that is locally advanced or metastatic and refractory to established forms of therapy. These patients must have archival tissue available and a lesion accessible for biopsy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2, life expectancy ≥ 12 weeks
- •Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
- •Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
- •Prior radiation therapy is permitted provided that patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive
- •Prior surgery is permitted provided that wound healing has occurred prior to registration
- •Fasting glucose ≤ 125 mg/dL (7 mmol/L) at baseline (all patients except those in the Diabetic Expansion Cohort). Patients in the Diabetic Expansion Cohort must have a fasting glucose of ≤ 150 mg/dL (8.3 mmol/L) at baseline. If patients in the Diabetic Expansion Cohort are being treated with non-insulinotropic oral antihyperglycemic therapy, doses must be stable for ≥ 4 weeks prior to registration
- •Potassium, calcium, and magnesium must be within normal limits (WNL). Electrolyte abnormalities will be permitted if they are not clinically significant and if treatment for the abnormality is initiated prior to Day 1
- •Neutrophil ≥ 1.5 x 10^9/L, Platelet (PLT) ≥ 100 x 10^9/L; bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN or ≤ 5 x UNL if patient has documented liver metastases; creatinine ≤ 1.5 x ULN
- •Accessible for repeat dosing and follow-up, including pharmacokinetic sampling
- •Patients must practice effective contraceptive measures throughout the study
- •Provide written informed consent
排除标准
- •History of any kind of stroke
- •History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
- •History of allergic reaction attributed to a similar compound as study drug.
- •Any type of active seizure disorder
- •Previously diagnosed brain metastases
- •Concurrent anticancer therapy
- •Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
- •Pregnant or breast-feeding females
- •Documented history of diabetes mellitus (all patients except those in the Diabetic Expansion Cohort). Patients in the Diabetic Expansion Cohort may not have Type 1 diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or insulin therapy
- •Use of drugs with a risk of causing QT interval prolongation within 14 days prior to Day 1 and while on study
- •Use of glucocorticoids within 14 days prior to Day 1 and while on study
- •History of significant cardiac disease unless well controlled (includes 2nd/3rd degree heart block, ischemic heart disease, QTc > 450 msec, poorly controlled hypertension, or congestive heart failure of New York Heart Association (NYHA) Class II or worse)
研究组 & 干预措施
OSI-906 QD
Experimental
Once per day
干预措施: OSI-906 (Drug)
OSI-906 BID
Experimental
Twice per day
干预措施: OSI-906 (Drug)
结局指标
主要结局
Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906
时间窗: 21 days
次要结局
- Safety profile; Pharmacokinetic (PK) profile; Pharmacodynamic relationships and preliminary antitumor activity(2.5 years)
研究者
研究点 (2)
Loading locations...
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