NCT04123704终止2 期
A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer
Xiang Zhang1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年9月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Efficacy: Progression-Free Survival at 24 Weeks (PFS24)
研究概览
简要总结
This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 100 mg daily, until their cancer worsens, or until they develop intolerable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women or men age 18 and older
- •Metastatic or locally advanced inoperable breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Note: Patients with bone-only disease are eligible if there is at least 1 lytic lesion that can be followed for response.
- •Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of
- •Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
- •Patient has archival tissue from metastatic or locally advanced breast cancer for the analysis of PTPN12 status
- •At least one prior line of chemotherapy with or without a PD-L1 or PD-1 antibody in the metastatic setting
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- •Normal organ and marrow function as defined below:
- •Absolute neutrophil count > 1000/mcL
- •Hemoglobin > 11 g/dL
- •Platelets > 100,000/mcL
- •Total bilirubin < 1.5 X normal institutional limits
- •Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 X institutional ULN or ≤ 5.0 × ULN for patients with documented liver metastases.
- •Creatinine within normal institutional limits
- •Creatinine clearance ≥ 30 mL/min
- •Normal left ventricular ejection (LVEF) function defined as normal left ventricular wall motion and ejection fraction of ≥ 50%.
- •If patient has brain metastasis, documented treatment and stability for at least 30 days by scans and off steroids at the time of enrollment
- •Women of child bearing age and actively menstruating must have a negative pregnancy test prior to starting study treatment.
- •If sexually active in a way that could lead to pregnancy, participant must agree to use a highly effective method of birth control starting at the time of informed consent and continuing throughout the study and for at least 3 months after the final dose of sitravatinib.
- •Ability to understand and the willingness to give informed consent
排除标准
- •Uncontrolled hypertension defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100, on two or more occasions within 30 days prior to enrollment.
- •Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
- •Untreated brain metastases.
- •Women who are pregnant or nursing
- •Concurrent metastatic disease of another tumor type
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sitravatinib
- •History of stroke, pulmonary embolus (PE), or myocardial infarction (MI)
- •Known proteinuria of ≥ 2 g urinary protein/24 h
- •HIV-positive participants
- •History of Hepatitis C or Hepatitis B infection
- •History of congestive heart failure (CHF), and/or LVEF less than 50%
- •Concurrent use of medications that prolong QTc (listed in Section 9, Table 11). These medications need to be discontinued at least 2 weeks prior to starting study treatment.
- •Concurrent medical condition that, in the sole judgment of the principal investigator, would make the patient inappropriate for trial participation.
研究组 & 干预措施
Sitravatinib
Experimental
Sitravatinib 100 mg daily
干预措施: Sitravatinib (Drug)
结局指标
主要结局
Efficacy: Progression-Free Survival at 24 Weeks (PFS24)
时间窗: 24 weeks
Progression-free survival 24 weeks after starting study treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, \>=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.
次要结局
- Time to Progression (TTP)(Up to 16 months)
- Objective Response Rate (ORR)(Up to 16 months)
- Clinical Benefit Rate (CBR)(Up to 16 months)
- Number of Participants With Grade 3 or Higher AEs(Up to 16 months)
研究者
Xiang Zhang
Professor
Baylor Breast Care Center
研究点 (1)
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