jRCT2031250648招募中不适用
A trial to learn how safe AZD9750 is and how well it works in people withmetastatic prostate cancer when given with or without other anticancer drugs (ANDROMEDA)
未提供0 个研究点目标入组 28 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
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
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Participant must be 18 years or more or the legal age at the time of signing the informed consent form.
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Documented metastatic disease.
- •Serum testosterone levels 50 ng/dL or less.
- •Evidence of disease progression with one of the following:
- •(a) PSA progression defined by a minimum of 3 rising PSA levels with an interval of 1 week or more between each determination.
- •(b) Radiographic progression of soft tissue disease by RECIST v1.1 with or without PSA progression.
- •(c) Radiographic progression of bone metastasis with 2 or more documented new bone lesions on a bone scan with or without PSA progression.
- •ECOG performance status score of 0 or
- •Adequate bone marrow and organ function.
- •Part A (Module 1)
- •(a) Part A1 dose escalation: at least 1 prior ARPI and, if applicable, at least 1 taxane-based chemotherapy (regardless of whether in HSPC or CRPC setting).
- •(b) Part A2 backfill: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies(regardless of whether in HSPC or CRPC setting).
- •Part B (Module 1)
- •(a) B1/B2 dose optimization/expansion: at least 1 but no more than 2 prior ARPIs and, if applicable, at least 1 but no more than 2 prior taxane-based chemotherapies (regardless of whether in HSPC or CRPC setting).
- •(b) B3 dose expansion (no taxane cohort): at least 1 but no more than 2prior ARPIs for metastatic prostate cancer (regardless of whether in HSPC or CRPC setting). No prior taxane is allowed for inclusion in this cohort.
排除标准
- •Participants with pathological finding consistent with any presence of small cell carcinoma, predominant neuroendocrine carcinoma, or any predominant histology other than prostate adenocarcinoma.
- •Brain metastases, or spinal cord compression.
- •Any clinically significant cardiac disorders including QT prolongation, abnormal electrocardiogram (ECG).
- •Any clinically significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, stroke.
- •Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism of AZD9750 and relevant combination IMPs.
- •Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] hemorrhagic stroke, proliferative diabetic retinopathy).
- •Prior treatment with an AR-PROTAC.
研究者
相似试验
招募中
1 期
A trial to learn if AZD9829 is safe and works alone and in combination with other treatments for participants with certain blood cancers.2023-506997-11-00Astrazeneca AB14
招募中
1 期
A trial to learn how safe AZD5335 is and if a drug called itraconazole changes how AZD5335 moves through the body over time in adults with ovarian, peritoneal, or fallopian tube cancer2025-522731-34-00AstraZeneca AB17
招募中
1 期
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy ParticipantsNCT07290283AstraZeneca176
招募中
3 期
A study on Major Adverse cardiovascular events in Patients with a History of Atherosclerotic cardiovascular disease events or at High Risk for a First EventCTRI/2025/10/095916AstraZeneca AB15,100
招募中
1 期
A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer DrugsProstate CancerNCT07336446AstraZeneca300