EUCTR2021-006227-17-SE进行中（未招募）1 期
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Malignancies (CERTIS1) - CERTIS1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •1 Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
- •2 Age = 18 years at the time of screening.
- •3 Eastern Cooperative Oncology Group performance status (ECOG PS: 0-2) with no deterioration over the previous 2 weeks.
- •4 Life expectancy = 12 weeks.
- •5 Progressive cancer at the time of study entry.
- •6 Patients must have histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria.
- •7 Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
- •8 Adequate organ and marrow function as defined by the protocol
- •9 Female subjects of childbearing potential: Must have negative pregnancy test result at screening and prior to each cycle administration of study treatment and must use at least one highly effective method of birth control.
- •10 Female subjects must not breastfeed and must not donate or retrieve ova for their own use, from screening to approximately 1 months after the last dose of study intervention.
- •11 Non-sterilised male participants who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to approximately 3 months after the last dose of study intervention
- •Other module specific criteria may apply
- •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 163
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •1 Treatment with any of the following:
- •(a) Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study intervention
- •(b) Any other anti-cancer treatment within 5 half-lives or 3 weeks for cytotoxic and non-cytotoxic treatment or 4 weeks for biological products
- •2 Major surgery within 4 weeks of the first dose of study intervention
- •3 Radiotherapy 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 intervention
- •4 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 intervention
- •5 Any known history of persisting (> 2 weeks) severe pancytopenia due to any cause
- •6 Spinal cord compression unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study intervention
- •7 History of uncontrolled seizures or with need for concurrent administration of more than 2 antiepileptic drugs, or history of epileptic disorder or any seizure history unrelated to tumour
- •8 History of severe brain injury or stroke
- •9 As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
- •10 Uncontrolled intercurrent illness within the last 12 months, including but not limited to, active interstitial lung disease, serious chronic GI conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
- •11 Any known predisposition to bleeding
- •12 Any of the following cardiac criteria:
- •(a) Mean resting corrected QT interval (QTcF) >450 milliseconds
- •(b) Any factors that increase the risk of QT prolongation or risk of arrhythmic events
- •(c) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG and clinically significant sinus node dysfunction not treated with pacemaker
- •13 Other 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/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention or coronary artery bypass grafting or cardiac valve replacement/repairment within 6 months
- •(e) Cardiomyopathy of any aetiology
- •(f) Presence of clinically significant valvular heart disease
- •(g) History of atrial or ventricular arrhythmia requiring treatment
- •(h) Transient ischaemic attack, or stroke within 6 months prior to screening
- •(i) Patients with symptomatic hypotension at screening
- •14 Patients with myelodysplastic syndrome/acute myeloid leukaemia
- •15 Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of the investigational product(s) (IP).
- •16 Known allergy or hypersensitivi
研究者
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