ACTRN12621000479808已完成1 期
A Phase 1/2, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
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
- •1. Ability to understand and be willing to sign an informed consent form.
- •2. Male or female, greater than or equal to 18 years old at the time of screening.
- •3. Diagnosis of histologically or cytologically confirmed:
- •a. Locally advanced or metastatic cancer (all solid tumours allowed). Patients must
- •be considered refractory or intolerant to standard-of-care (SOC) therapies or have
- •refused SOC therapy (Phase 1a, monotherapy), OR
- •b. Locally advanced or metastatic cancer that are thought to respond to CDK4/6
- •inhibition, or non-malignant tumours impacting QOL (e.g. teratoma’s, invasive
- •neurofibroma’s) that may respond to CDK4/6 inhibition (based on optional
- •tumour molecular/genetic profile). Patients must be considered refractory or intolerant to SOC therapies or have refused SOC therapy, or have invasive non malignant tumours that cannot be treated with surgery alone (Phase 1b, monotherapy), OR
- •c. High-grade glioma, such as GBM. Patient must also:
- •i. Have completed radiation therapy, with concomitant TMZ plus a minimum of 1-3 full cycles of TMZ monotherapy post RTx/CTx as their SOC first-line treatment.
- •ii. Have recurrent/progressive high-grade glioma >/= 3-6 months post first-line SOC treatment.
- •4. ECOG performance status of 0 to 2.
- •5. Able to take oral medications.
- •6. QT interval corrected using the Fridericia method (QTcF) less than or equal to 450 msec for males and less than or equal to 460 msec for females at screening and on Day 1, prior to dose administration.
- •7. Evidence of adequate cardiac function.
- •8. Evidence of adequate hepatic function at screening.
- •9. Adequate haematology laboratory assessment at screening.
- •10. Adequate renal function.
- •11. Adequate coagulation laboratory assessments at screening.
- •12. Female patients must
- •a. Be of non-child-bearing potential, or
- •b. If of child-bearing potential, must agree not to attempt to become pregnant.
- •13. Male patients must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception
- •14. Estimated life expectancy of at least 3 months, in the opinion of the Investigator.
- •15. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •1. Prior treatment with a CDK4/6 inhibitor, unless first approved by medical monitor.
- •2. Patients with symptomatic primary central nervous system (CNS) tumour, symptomatic CNS metastases, or untreated spinal cord compression that have moderate or severe symptoms.
- •3. Uncontrolled pleural effusion(s), pericardial effusion or ascites.
- •4. Evidence of abnormal cardiac function.
- •5. Cardiac arrhythmia that is considered unstable and requiring medication for stabilisation.
- •6. Unable to swallow oral medications.
- •7. Gastrointestinal (GI) conditions that, in the opinion of the Investigator, could affect the absorption of study drug.
- •8. History of other malignancy within the past 2 years.
研究者
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