Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
赞助:
Vanderbilt-Ingram Cancer Center
合作者:
信息的提供 (责任方):
Ingrid Mayer, MD，Vanderbilt-Ingram Cancer Center
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 24, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Incidence of adverse events[ Time Frame: Up to 30 days after completing treatment ] Adherence to treatment (participants will be provided a pill diary to record when they take their medication. Study staff will collect the pill diary from participants at their clinic visits).[ Time Frame: Up to 12 months ] Summarized change of FACT-G score (scale = 0 to 4)[ Time Frame: Up to 12 months ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence | ||
| 正式标题 ICMJE | A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence | ||
| 简要概况 | This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body. |
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| 详细说明 | PRIMARY OBJECTIVES: I. To assess the safety and feasibility of ifetroban sodium (ifetroban) administration in patients with malignant solid tumors at high risk of metastatic recurrence, after completion of all planned (neo)adjuvant locoregional and systemic therapies. SECONDARY OBJECTIVES: I. To assess rate of metastatic recurrence after completion of ifetroban in patients with malignant solid tumors. EXPLORATORY OBJECTIVES: I. To quantify pharmacodynamic markers of ifetroban effects. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP 1 (IFETROBAN): Patients receive ifetroban sodium orally (PO) once daily (QD). Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. GROUP 2 (PLACEBO): Patients receive a placebo PO QD. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then up to 12 months. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
60 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2022 | ||
| 预计主要完成日期 | November 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Signed and dated written informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. - One of the following current diagnoses: - Stage IIa to III triple negative breast cancer (TNBC). - Stage I to II pancreatic adenocarcinoma. - Lung Cancer. - Stage IIa to III non-small cell lung cancer (NSCLC). - Limited stage small cell lung cancer (SCLC). - Stage IIa to III esophageal or gastroesophageal (GE) junction cancers (squamous cell carcinoma [SCCA] or adenocarcinoma). - Stage IIa to III stomach cancer. - Patients must have completed all standard locoregional and systemic therapy for their cancer. - Administration of an investigational agent prior to enrollment needs to be completed at least 30 days prior to enrollment. - Patients must have recovered (=< grade 1 toxicities) from effects of local (surgery, radiation) or systemic treatments. - Platelet count >= 100,000 per mL of blood. - Hemoglobin >= 9/g/dL (may have been transfused). - Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation. - Total serum bilirubin =< 1.5 times upper limit of normal (ULN). - Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/serum glutamate-pyruvate transaminase [SGPT]) =< 2.5 x ULN. - International normalized ratio (INR) below upper limit of normal (ULN). - Female patients of childbearing potential and non-sterile males must agree to use at least two methods of acceptable contraception from 15 days prior to first trial treatment administration until at least 5 months after study participant's final dose of study drug. * Note: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women. Non-sterile males are those who have not had a vasectomy with documentation of the absence of sperm in the ejaculate. - Patients unable to read/write in English are eligible to participate in the overall study but will not participate in the Patient-Reported Outcome questionnaires throughout the trial. - Re-enrollment of a subject that has discontinued the study as a pre-treatment screen failure (i.e. a consented patient who did not receive study drugs) is permitted. If reenrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated. Exclusion Criteria: - Clinical evidence of residual or distant disease after completion of standard treatment. - Current use of anti-platelet drugs (acetylsalicylic acid [ASA], nonsteroidal anti-inflammatory drugs [NSAIDs], clopidogrel, argatroban, etc.) or anticoagulants (warfarin, heparin products, etc.). - Active malignancy within 5 years prior to current diagnosis except for in situ disease or cancer with very high curability rate (i.e. testicular cancer, etc.). - Uncontrolled co-morbid serious systemic illnesses that in the opinion of the investigator could compromise therapeutic safety. - No concurrent anticancer therapy. Required washout from prior therapy: - Chemotherapy: 21 days. - Major surgery: 14 days (provided wound healing is adequate). - Radiation: 7 days. - Investigational/Biologic Therapy: 30 days. - Current symptomatic congestive heart failure (New York Heart Association > class II), unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled hypertension (systolic > 160 mmHg or diastolic > 100mmHg). Or any of the following occurring within 6 months (180 days) prior to first dose of study drugs: Myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack. (Use of antihypertensive medication to control blood pressure is allowed.) - Ongoing peptic ulcer disease requiring treatment. History of gastrointestinal bleed. Severe gastro-esophageal reflux disease requiring treatment. - History of bleeding diathesis. - Planned elective major surgical intervention while taking ifetroban. - Pregnant or breastfeeding females. - Prisoners or subjects who are involuntarily incarcerated. - Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient's study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Ingrid Mayer, MD，Vanderbilt-Ingram Cancer Center | ||
| 研究赞助商 ICMJE | Vanderbilt-Ingram Cancer Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Vanderbilt-Ingram Cancer Center | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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