CTRI/2012/12/003208暂停1 期
An Open Label Multicentre Phase 1 Study of Oral IGF-1R Inhibitor PL225B in Subjects with Advanced Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- To determine the maximum tolerated dose and dose limiting toxicity (ies).
研究概览
简要总结
An open label multicentre Phase 1 study of oral IGF-1R inhibitor PL225B in subjects with advanced refractory solid tumors to determine the maximum tolerated dose and dose limiting toxicity (ies) and also to evaluate the safety, tolerability, pharmacokinetics and efficacy of PL225B in subjects of advanced refractory solid tumors with type 2 diabetes mellitus in a Diabetes Expansion Cohortxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having histologically and/or cytologically confirmed non-haematological malignancy that is metastatic or unresectable and for which standard curative or palliative treatment does not exist or is no longer effective
- •Subjects should have measurable or evaluable disease
- •Subjects of either sex, of all races and ethnic groups, and more than equal to 18 years of age
- •ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- •Subjects with life expectancy of at least 4 months
- •Subjects with fasting plasma glucose less than equal to 125 mg/dl and HbA1c less than 6.5 % at screening Subjects with fasting plasma glucose less than equal to 150 mg/dL and HbA1c less than equal to 7.0 % at screening for the Diabetes Expansion Cohort
- •For the Diabetes Expansion Cohort.
- •Subjects with known history of type 2 diabetes mellitus that are well-controlled on a stable dose of oral anti-diabetic agents such as metformin and/or sulfonylureas for 4 weeks prior to screening.
- •Subjects willing for repeat oral dosing and follow-up, including pharmacokinetic sampling
- •Women of childbearing potential and men willing to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilised
- •Ability to understand and the willingness to provide a written informed consent document.
排除标准
- •Subjects who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before the first study drug administration and have not recovered (to AEs less than equal to Grade 2) from the toxic effects from any prior therapy
- •Subjects having received any other investigational agents within 4 weeks prior to the first study drug administration and have not recovered completely (to AEs less than equal to Grade 2) from the side effects of the earlier investigational agent
- •Subjects with documented history of diabetes mellitus except for the Diabetes Expansion Cohort
- •For the Diabetes Expansion Cohort – Subjects who have type 1 diabetes mellitus, maturity onset diabetes of the young, hyperglycemia due to reasons other than type 2 diabetes mellitus
- •For the Diabetes Expansion Cohort.
- •Subjects who currently require insulin, thiazolidinediones, dual proliferator-activated receptors (PPAR) agonists, glucagon-like peptide (GLP-1) analogues, dipeptidyl peptidase (DPP-IV) inhibitors or have received the same in the 4 weeks prior to screening
- •Subjects with known complications of diabetes like diabetic nephropathy or diabetic retinopathy
- •Subjects with known brain metastases
- •Subjects with gastro intestinal abnormalities including inability to take oral medication, malabsorption or other conditions like chronic inflammatory bowel disease that may affect absorption
- •Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months
- •Subjects on warfarin. Prophylactic anticoagulation with low molecular weight heparin is allowed.
- •Subjects with history of anaphylaxis or angio-edema, bronchial asthma, peptic ulcer and clinically significant food or drug allergy
- •Subjects with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Women who are pregnant or nursing.
结局指标
主要结局
To determine the maximum tolerated dose and dose limiting toxicity (ies).
时间窗: Subjects will receive study drug on a daily basis for twenty-one (21) days according to the dose and schedule specified for a particular cohort of therapy. This 21 day administration will define a treatment cycle. Subjects may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, or withdrawal from the protocol as specified
次要结局
- 1. To characterize the safety profile of PL225B(2. To characterize the pharmacokinetic profile of PL225B)
研究者
研究点 (5)
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