EUCTR2011-005718-12-ES进行中（未招募）1 期
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of the Oral ALK/EGFR Inhibitor AP26113
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 137
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
- •All patients must meet all the following eligibility criteria for study entry.
- •1. All patients must have tumor tissue available for analysis. If sufficient tissue is not available, patients must undergo a biopsy to obtain adequate samples. Patients with less tissue than required can be enrolled only with prior approval from the Sponsor.
- •In the expansion cohorts, for which failure of prior therapy is specified (expansion cohorts 2 and 3), tumor tissue must be obtained following failure of the prior therapy.
- •2. Must have measurable disease by RECIST (version 1.1).
- •3. Male or female patients >= 18 years old.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- •5. Minimum life expectancy of 3 months or more.
- •6. Adequate renal and hepatic function as defined by the following criteria:
- •i. Total serum bilirubin <= 2 x upper limit of normal (ULN);
- •ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
- •<= 2.5 x ULN (or <= 5 x ULN if liver function abnormalities are due to underlying malignancy);
- •iii. Serum creatinine < 2 x ULN;
- •iv. Serum albumin >= 2 g/dL.
- •7. Adequate bone marrow function as defined by the following criteria:
- •i. Absolute neutrophil count (ANC) >= 1500/µL;
- •ii. Platelets >=75,000/µL;
- •iii. Hemoglobin >= 9.0 g/dL.
- •8. Normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of <= 450 ms in males or <= 470 ms in females.
- •9. For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
- •10. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout study participation.
- •11. Signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study.
- •12. Willingness and ability to comply with scheduled visits and study procedures.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients are not eligible for participation in the study if they meet or have any of the following exclusion criteria:
- •1. Received an investigational agent within 14 days prior to initiating AP26113.
- •2. Received systemic anticancer therapy or radiation therapy within 14 days prior to initiating AP26113
- •a. Except that for cohorts 3 and 4, EGFR TKI therapy is allowed up to 72 hours
- •prior to initiating AP26113.
- •3. Major surgery within 28 days prior to initiating AP26113.
- •4. Active metastases in the brain or central nervous system (CNS). If present, metastases must be stable for at least 8 weeks as documented by magnetic resonance imaging (MRI) or, in the case of meningeal involvement, by a negative lumbar puncture prior to study entry.
- •5. Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
- •a. Myocardial infarction, unstable angina and/or congestive heart failure within
- •3 months prior to first dose of AP26113;
- •b. History of clinically significant (as determined by the treating physician) atrial
- •arrhythmia or any ventricular arrhythmia.
- •6. Uncontrolled hypertension (Diastolic blood pressure [BP] > 100 mm Hg; Systolic
- •> 150 mm Hg).
- •7. Prolonged QTcF interval, or being treated with medications known to cause Torsades
- •de Pointes (refer to Attachment 4).
- •8. Ongoing or active infection. The requirement for IV antibiotics is considered active infection.
- •9. Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history.
- •10. Pregnant or breastfeeding.
- •11. Malabsorption syndrome or other gastrointestinal illness that could affect oral
- •absorption of AP26113.
- •12. Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the safety of the drug.
研究者
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