EUCTR2016-001352-21-ES进行中（未招募）1 期
A phase I/ II, open label study to assess the efficacy and safety of ABTL0812 in combination with paclitaxel and carboplatin in patients with advanced endometrial cancer or squamous NSCLC
Ability Pharmaceuticals, S0 个研究点目标入组 80 人开始时间: 2016年7月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients =18 years of age
- •For endometrial cancer: Patients with histologically or radiological/cytologically confirmed diagnosis of advanced, metastatic or recurrent endometrial cancer
- •For squamous NSCLC: Patients with histologically or radiological/cytologically confirmed diagnosis (non irradiable IIIb stage or stage IV)
- •Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses.
- •Life expectancy = 12 weeks in the opinion of the investigator
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one target lesion to be used to assess response.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Contraception: Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug.
- •Adequate bone marrow function defined as:
- •- absolute neutrophil count = 1.5x109/L
- •- platelet count = 100x109/L
- •- hemoglobin = 9.0 g/dL
- •Total bilirubin = 1.5 x upper limit of normal
- •AST = 2.5 times upper limit of normal (ULN) (=5 times the ULN in patients with evidence of liver metastases)
- •Alkaline phosphatase = 2.5 times ULN (=5 times the ULN in patients with evidence of liver metastases)
- •Glomerular filtration rate = 50 mL/min
- •Serum creatinine =1.5 mg/dL
- •Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to = grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.02).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway.
- •Patients with symptomatic brain metastases.
- •Patients with gastrointestinal abnormalities including inability to take oral medications, malabsorption syndromes or other clinically significant gastrointestinal abnormalities that may impair the absorption of the investigational medicinal product.
- •Pregnancy or lactation.
- •Patients with myocardial infarction within = 12 months prior to study entry, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
- •Evidence of pre-existing uncontrolled hypertension.
- •Patients with known Hepatitis B or C or human immunodeficiency virus (HIV) infection with non-controlled disease according to the treating physician.
- •Patients with any other medical conditions (such as psychiatric illness, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
研究者
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