JPRN-jRCT2080225373已完成1 期
A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti- tumor Activity of AZD9833 in Japanese Women with ER Positive, HER2 Negative Advanced Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
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
- 年龄范围
- >= 20age old 至 <= 130age old（—）
- 性别
- Female
入选标准
- •1. Signed written informed consent.
- •2. >= 20 years.
- •3. Any menopausal status:
- •Post-menopausal defined according to standard criteria in the protocol.
- •4. Histological or cytological confirmation of adenocarcinoma of the breast.
- •5. Documented positive estrogen receptor status of primary or metastatic tumor tissue, according to the local laboratory parameters. HER-2 negative.
- •6. Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP.
- •7. Prior chemotherapy, endocrine therapy and other therapy in the advanced setting is restricted as follows:
- •a. No more than 2 lines of chemotherapy for advanced disease.
- •b. Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
- •c. There is no limit on the number of lines of prior endocrine therapies.
- •d. Prior treatment with CDK4/6 inhibitors is permitted.
- •8. At least one lesion (measurable and/or non-measurable, as per RECIST 1.1) that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray; or clinical examination.
- •9. Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1
排除标准
- •1. Intervention with any of the following:
- •a. Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- •b. Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 (CYP) 3A4/5 sensitive CYP2B6 substrates and drugs which are substrates of CYP2C9 and/or CYP2C19.
- •c. Drugs that are known to prolong QT and have a known risk of Torsades de Pointes.
- •d. Radiotherapy with a limited field of radiation for palliation within one week of the first dose of IMP, radiotherapy to more than 30% of the bone marrow or a wide field of radiation within 4 weeks of the first dose of IMP.
- •e. Major surgical procedure or significant traumatic injury.
- •2. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting IMP.
- •3. Presence of life-threatening metastatic visceral disease.
- •4. Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
- •5. Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833.
- •6. History of another primary malignancy.
- •7. Male subjects are excluded from this study.
- •8. History of hypersensitivity to active or inactive excipients of AZD9833.
- •9. The following cardiovascular criteria: QTcF >470 ms, resting heart rate <45 bpm, clinically significant abnormalities of resting electrocardiogram, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, left ventricular ejection fraction <50%.
- •10. Inadequate bone marrow reserve or organ function
- •11. Involvement in the planning and conduct of the study.
- •12. Judgment by the investigator that the patient should not participate in the study
研究者
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