ACTRN12618001070224招募中1 期
A phase 1 dose escalating study to determine incidence of dose limiting toxicities of single agent ATX-101 given by intravenous infusion every week in patients with advanced solid tumours
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Advanced disease (solid tumour) for which conventional anti-tumour treatment has been exhausted or has been refused
- •- Measurable or non-measurable (but radiologically evaluable) disease on CT/MRI scan
- •with at least one lesion outside previously irradiated areas
- •- Have an ECOG Performance status 0-2
- •- Life expectancy of at least 3 months
- •- Meet the following laboratory requirements:
- •Absolute lymphocyte count greater than or equal 0.8 x 109/L
- •Platelet count greater than or equal 75 x 109/L
- •Activated partial thromboplastin time (aPTT)/prothrombin time (PT) less than or equal to 1.5 x the upper limit of normal (ULN)
- •Total bilirubin level less than or equal to 1.5 x ULN
- •Aspartate transaminase (AST) and Alanine Aminotransferase (ALT) less than or equal to 2.5 x ULN
- •(less than or equal to 5 x ULN if liver metastasis present)
- •Creatinine less than or equal to 1.5 x ULN
- •Albumin greater than or equal to 30 g/
排除标准
- •1. Have received an investigational drug within 4 weeks
- •2. Concurrent anticancer treatment within 21 days or 5x (five times) their half-lives (whichever is shorter) before the first dose of trial treatment
- •3. Use of hormonal agents within 7 days before start of trial treatment, except for subjects with castration-resistant prostate cancer (CRPC), who may remain on treatment with luteinizing hormone–releasing hormone agonists or antagonists
- •a. Note: Subjects receiving bisphosphonate or denosumab are eligible provided that treatment was initiated more or equal to 14 days before first dose of treatment.
- •4. Anticipated requirement for surgery or initiation of anti-cancer therapy during the study period
- •5. Have not recovered from AEs (more or equal to CTCAE Grade 2 other than alopecia) due to agent(s) administered more than 4 weeks earlier
- •6. Cardiac failure (per New York Heart Association [NYHA] functional classification) of more than Grade 2.
- •7. Evidence or history of clinically significant cardiac disease including congestive heart failure, unstable angina, acute myocardial infarction or cerebrovascular accident within the last six months, and symptomatic arrhythmia requiring therapy (with the exception of extra systoles or minor conduction abnormalities and controlled and well-treated chronic atrial fibrillation).
- •8. QTcF more than 460 ms
- •9. Active central nervous system (CNS) metastases. Subjects with known CNS metastases must have received previous radiotherapy or surgery at least two weeks prior to receiving ATX-101. Any residual neurological deficit must be stable off corticosteroids.
- •10. Lymphangitic carcinomatosis
- •11. Leptomeningeal involvement
- •12. Major surgery within 3 weeks of screening
- •13. Current acute or chronic disease, other than the study indication, that would increase the expected risk of exposure to the investigational product or would be expected to interfere with the planned evaluations, in the judgment of the Investigator
- •14. Breastfeeding or pregnant as confirmed by a positive serum beta human chorionic gonadotropin (ß-HCG) pregnancy test at screening or at subsequent clinic visits
- •15. Unwilling or unable to follow protocol requirements
- •16. Known positive status of Human immunodeficiency virus (HIV) and/or active Hepatitis B or C. In subjects with a history of Hepatitis B or Hepatitis C infection, resolution of infection must be demonstrated by negative serology for Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) ribonucleic acid (RNA) must be demonstrated at least 6 weeks following antiviral therapy.
- •17. History of severe allergy (requiring hospital care), severe reaction to any drug, or any known or suspected allergies or sensitivities to the study drug constituents.
- •18. Inadequate venous access to allow collection of blood samples.
研究者
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