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临床试验/EUCTR2016-005039-34-FR
EUCTR2016-005039-34-FR进行中（未招募）1 期

Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

Astex Pharmaceuticals, Inc.0 个研究点目标入组 200 人开始时间: 2018年2月27日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
200
研究概览入排标准研究者记录与标识符相似试验

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

  • •Subjects must fulfill all of the following inclusion criteria.
  • •1. Able to understand and comply with the protocol and study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure is performed.
  • •2. Men and women 18 years of age or older.
  • •3. Subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available.
  • •4. Subjects must have measurable disease according to RECIST v1.1, or evaluable disease that can be reliably and consistently followed.
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • •6. Acceptable organ function, as evidenced by the following laboratory data:
  • •a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.0 × upper limit of normal (ULN).
  • •b. Total serum bilirubin =1.5 × ULN.
  • •c. Absolute neutrophil count (ANC):
  • •o (except subjects with known lymphoma): =1500 cells/mm3.
  • •o subjects with known lymphoma: =1000 cells/mm3 (=750 cells/mm3 for subjects with lymphoma in bone marrow).
  • •d. Platelet count:
  • •o (except subjects with known lymphoma): =100,000 cells/mm3.
  • •o subjects with known lymphoma: =50,000 cells/mm3 (=25,000 cells/mm3 for subjects with lymphoma in bone marrow).
  • •e. Serum creatinine levels =1.5 × ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measured creatinine clearance =50 mL/min.
  • •7. Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and all men with female partners of child-bearing potential must be practicing 2 medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with study drug and for at least 3 months after completing treatment
  • •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 160
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 40

排除标准

  • •1. Hypersensitivity to ASTX660, excipients of the drug product, or other components of the study treatment regimen.
  • •2. Poor medical risk because of systemic diseases (eg, active uncontrolled infections) in addition to the qualifying disease under study.
  • •3. Life-threatening illness, significant organ system dysfunction, or other condition that, in the investigator’s opinion, could compromise subject safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of ASTX660.
  • •4. History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
  • •a) Abnormal left ventricular ejection fraction (LVEF; <50%) on echocardiogram (ECHO) or multiplegated acquisition scan (MUGA). [Applies to Phase 1 only; ECHO/MUGA scans are not performed in Phase 2.]
  • •b) Congestive cardiac failure of = Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as subjects with marked limitation of activity and who are comfortable only at rest.
  • •c) Unstable cardiac disease including unstable angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
  • •d) History or presence of complete left bundle branch block, heart block, cardiac pacemaker or significant arrhythmia.
  • •e) Concurrent treatment with any medication that prolongs QT interval and may induce torsades de pointes, and which cannot be discontinued at least 2 weeks before treatment with ASTX660. [Applies to Phase 1 only.]
  • •f) Personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy.
  • •g) Screening 12-lead ECG with measurable QTc interval (according to either Fridericia's or Bazett’s correction) of =470 msec).
  • •5. Known history of human immunodeficiency virus (HIV) infection, or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  • •6. Grade 2 or greater neuropathy. [Applies to Phase 1 only.]
  • •7. Known brain metastases, unless stable or previously treated.
  • •8. Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
  • •9. Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX660), as follows:
  • •Cytotoxic chemotherapy or radiotherapy within 3 weeks prior and any encountered treatment-related toxicities (excepting alopecia) not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
  • •Monoclonal antibodies within 4 weeks prior and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].
  • •Investigational drugs (small molecules or biologics) within the longer of 2 weeks or 5 half-lives prior to study treatment and any encountered treatment-related toxicities not resolved to Grade 1 or less [Phase 1] or Grade 2 or less [Phase 2].

研究者

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