EUCTR2021-005238-40-BE进行中（未招募）1 期
A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants with Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EQRx, Inc.
- 入组人数
- 100
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. Is capable of giving signed informed consent. This includes compliance with the requirements and restrictions listed in the study informed consent form (ICF) and in this protocol.
- •2. Must be at least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place, at the time of giving signed informed consent.
- •Type of Participant and Disease Characteristics
- •3. Has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor-positive breast cancer by local laboratory.
- •4. Breast cancer is also HER2-negative and advanced (locoregionally recurrent; not amenable to curative therapy, eg, surgery and/or radiotherapy; or metastatic) and meets one of the following criteria:
- •Newly diagnosed advanced/metastatic breast cancer, treatment-naïve.
- •Relapsed with documented evidence of relapse following neoadjuvant (adjuvant) endocrine therapy, with no treatment for advanced/metastatic disease.
- •Relapsed with documented evidence of relapse following completion of adjuvant endocrine therapy, then subsequently progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen or an AI) for advanced/metastatic disease.
- •Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one (1) line of endocrine therapy (with either tamoxifen, exemestane, or an AI [other than fulvestrant]).
- •5. Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1.
- •6. Has adequate bone marrow and organ function, as defined by all of the following laboratory values:
- •Absolute neutrophil count (ANC) = 1.5 × 109/L
- •Platelets = 100 × 109/L
- •Hemoglobin = 9.0 g/dL
- •International normalized ratio (INR) = 1.5
- •Creatinine clearance (CLcr) = 60/mL, as estimated by Cockcroft-Gault equation
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) below
- •2.5 × upper limit of normal (ULN)
- •Total bilirubin = 1.5 × ULN; OR, for participants with well-documented Gilbert’s Syndrome, direct bilirubin within normal range of the central laboratory
- •7. Baseline QTc interval is < 470 msec.
- •8. Is able to take/swallow oral medications.
- •9. Has received a locally approved vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- •Sex and Contraceptive/Barrier Requirements
- •10. Must meet all of the applicable requirements for pregnancy and contraception (...)
- •For the complete information on the inclusion criteria” please check the Protocol section 5.1
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. Has symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy, per the Investigator’s best judgment.
- •2. Has peritoneal carcinomatosis.
- •3. Has inflammatory breast cancer at Screening.
- •4. Has central nervous system (CNS) involvement, unless participant is at least 4 weeks from prior therapy completion to starting study treatment, has stable CNS tumor at the time of Screening, and is not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
- •5. Has any clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- •6. Has a history of prolonged QT syndrome or Torsades de Pointes.
- •Prior/Concomitant Therapy
- •7. Has received prior treatment with chemotherapy (except neoadjuvant/adjuvant chemotherapy), or with any CDK4/6 inhibitor.
- •8. Has received prior treatment with fulvestrant.
- •9. Use of systemic estrogens (eg, hormonal contraception, hormone replacement therapy [HRT]).
- •10. Is currently receiving any of the following substances and cannot be discontinued 14 days prior to starting lerociclib:
- •Known strong or moderate CYP3A inducers or strong inhibitors of CYP3A
- •Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
- •Diagnostic Assessments
- •11. Ejection fraction of = 45% on echocardiogram performed within the past 12 months, or documented history of congestive heart failure with reduced ejection fraction.
- •12. Oral temperature of > 38°C at Screening, or any evidence of SARS-CoV-2 infection.
- •13. Interstitial pneumonia or severe impairment of lung function, with the latter defined as having vital capacity AND diffusing capacity of the lung for carbon monoxide (DLCO) that are = 50% of the normal predicted values OR having an oxygen (O2) saturation at rest in ambient environment of = 88%.
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