EUCTR2020-001642-18-ES进行中（未招募）1 期
A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations with Anti-cancer Agents in Patients with Advanced Haematological Malignancies - D8230C00002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
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
- •1. Participant must be >/= 18 years of age at the time of signing the informed consent.
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of 3.Documented active disease requiring treatment that is relapsed or refractory defined as:
- •a. Recurrence of disease after response to prior line(s) of therapy,or
- •b. Progressive disease after completion of or on the treatment regimen preceding entry into the study
- •4. Adequate organ function at screening as defined in the protocol
- •5. Uric acid level < upper limit of normal (ULN). If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
- •1. Participants must comply with the exclusion criteria described Core module
- •2. Participants with histologically confirmed, relapsed or refractory DLBCL, and where in the opinion of the investigator, a clinical trial is the best option for next treatment based on response and/or tolerability to prior lines of therapy.
- •´All-comer´ participants with relapsed or refractory large B-cell lymphoma including subtypes such as DLBCL NOS, HGBCL, PMBCL, or large B-cell lymphoma transformed from indolent B-cell lymphomas (including Richter Syndrome, transformed Follicular Lymphoma, transformed Marginal Zone Lymphoma):
- •- Diagnosis must be confirmed by biopsy and be immunohistologically characterised
- •- Tumour tissue must also be available for sending to AstraZeneca for central cell of origin/pathology testing.
- •All participants in Part A (dose setting) must consent to and provide archival tumour specimens, preferably in the form of a formalin fixed paraffin embedded block (tissue derived from the diagnostic tumour or a metastatic site). If this is not possible, an appropriate number of slides of freshly prepared unstained 5 micron sections from the archival tumour block may be provided. Archival tumour specimens must be obtained within 24 months before the first dose of investigational product. If archival material is unavailable or unsuitable for use, participants must consent to and undergo a tumour biopsy during the screening period. A newly obtained biopsy is strongly encouraged and preferred.
- •Participants with relapsed or refractory de novo DLBCL, GCB or non-GCB subtype:
- •-Must have received standard of care first line therapy.
- •-Diagnosis must be confirmed by biopsy and be immunohistologically characterised.
- •-A newly obtained tumour biopsy is mandatory at screening to confirm cell of origin status and determine DLBCL subtype.
- •A recent biopsy that was taken as part of standard of care prior to screening consent for this study is acceptable if no treatment was administered between the biopsy and the first dose of study treatment, and the biopsy was taken within 60 days prior to receiving the first dose.
- •3. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (according to the Lugano criteria).
- •4. Participants must have failed at least 2 prior therapies for the treatment of current disease, are not eligible for curative treatment options, and have no standard therapy available.
- •5. Adequate haematologic function, without transfusion and growth factor support for >/= 14 days before screening, as defined in the Protocol
- •6. All participants must be willing and able to provide mandatory baseline bone marrow biopsy/aspirate.
- •Are the trial subjec
排除标准
- •Core Exclusion Criteria
- •1. Patients with non-secretory myeloma
- •2. Except alopecia, unresolved toxicities from prior therapy >CTCAE Grade 1 at starting study treatment
- •3. Presence or history of central nervous system (CNS) lymphoma, leptomeningeal disease or spinal cord compression
- •4. Prior non-haematological malignancy except for the following:
- •(a)Malignancy treated with curative intent with no evidence of active disease present for more than 2 years before screening and thought at low risk of recurrence by treating physician.
- •(b) Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
- •(c) Adequately treated carcinoma in situ without current evidence of disease
- •5.Known history of infection with human immunodeficiency virus (HIV).
- •6. Serologic status reflecting active hepatitis B or C infection:
- •(a) Hepatitis B core antibody (anti-HBc) positive, surface antigen negative patients must have a negative polymerase chain reaction (PCR) result before enrolment. Hepatitis B surface antigen positive or hepatitis B PCR positive patients will be excluded.
- •(b) Hepatitis C antibody positive patients must have a negative PCR result before enrolment. Hepatitis C PCR positive patients will be excluded.
- •7. Any of the following cardiac criteria:
- •(a) Resting QT interval corrected using Fridericia’s formula(QTcF) >/=470 msec obtained from a single electrocardiogram (ECG).
- •(b) Any clinically important abnormalities in rhythm (excepting patients with a pacemaker in place), conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block).
- •(c) Factors elevating the risk of QTc prolongation or arrhythmic events such as congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age. Concomitant medications known to prolong QTc should be used with caution and cannot be used starting with the first dose of study drug and through the DLT review period or during the scheduled ECG assessments.
- •8. Documented history and treatment of adrenal gland insufficiency or pancreatitis
- •9. History of severe allergic or anaphylactic reactions to BH3 mimetics or hypersensitivity to excipients of study treatment
- •10. History, within the previous 6 months, of (a) coronary artery bypass graft; (b) angioplasty; (c) vascular Stent: a patient who has had a cardiac or arterial Stent currently or in the preceding 6 months will not be eligible for the study. However, a who has had a venous Stent to prevent life-threatening conditions, currently or in the preceding 6 months, will be eligible. (d) myocardial infarction; (e) angina pectoris; (f) congestive heart failure (New York Heart Association Class>/=2);(g) ventricular arrhythmias requiring continuous therapy; (h) uncontrolled atrial fibrillation; (i) haemorrhagic or thrombotic stroke, including transient ischemic attacks or other CNS bleeding.
- •Module 1 – Exclusion Criteria
- •1 Patients must comply with the exclusion criteria described Core module
- •2 Treatment with any of the following: (a) Prior BTK inhibitor treatments
- •3 Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, s
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