EUCTR2020-002688-77-CZ招募中1 期
A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 864
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- •2Age = 18 at the time of screening
- •3Patients must have histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria.
- •4Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
- •5Life expectancy = 12 weeks
- •6Progressive cancer at the time of study entry
- •7Patients must have evaluable disease as per RECIST v1.1
- •8Female subjects of childbearing potential:Must have negative pregnancy test result at screening and prior to each administration of study treatment and must use at least one highly effective method of birth control.
- •9Female subjects must not breastfeed and must not donate or retrieve ova for their own use, from screening to approximately 6 months after the last dose of study treatment with IMP.
- •10Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to approximately 6 months after the last dose of AZD5305 IMP.
- •11. Adequate organ and marrow function as defined by the protocol.
- •12. For expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory except if stated that it is optional in a specific Module.
- •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 648
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 216
排除标准
- •1Treatment with any of the following:
- •(a) Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
- •(b) Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is longer) of the first dose of study treatment
- •(c) Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
- •(d) Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
- •2Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong and moderate inhibitors or inducers.
- •3Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
- •4Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.
- •5Major surgery within 4 weeks of the first dose of study treatment.
- •6Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
- •7 With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment.
- •8Any history of persisting (> 2 weeks) severe pancytopenia due to any cause
- •9Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment
- •10As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- •11Patients with any known predisposition to bleeding
- •12Any of the following cardiac criteria:
- •-Mean resting corrected QT interval (QTcF) > 450 milliseconds or QTcF<340 milliseconds
- •-Any factors that increase the risk of QT prolongation, shortening or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long or short QT syndrome, family history of long QT syndrome, familial short QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong or shorten the QT interval.
- •-Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG and clinically significant sinus node dysfunction not treated with pacemaker.
- •13Other cardiovascular diseases as defined by any of the following:
- •(a)Symptomatic heart failure,
- •(b)uncontrolled hypertension,
- •(c)hypertensive heart disease with significant left ventricular hypertrophy
- •(d)acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
- •(e)cardiomyopathy of any etiology
- •(f)presence of clinically significant valvular heart disease
- •(g)history of atrial or ventricular arrhythmia requiring treatment;
- •subjects with atrial fibrillation
- •and optimally controlled ventricular rate (<100 beats per minute)
- •are permitted
- •(h)subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
- •(i)transient ischaemic attack, or stroke within 6 months prior to screenin
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