NCT03694249进行中（未招募）2 期
A Pilot Trial of Ifetroban, A Thromboxane A2 Receptor Antagonist, in Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Signed and dated written informed consent.
- •Subjects ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Current diagnosis of any stage I to III malignant solid tumor at high risk of metastatic recurrence (deemed by treating physician as patients with ≥ 50% chance of cancer metastatic recurrence within 5 years of diagnosis)
- •Patients must have completed all standard locoregional and systemic therapy for their cancer within 120 days of study enrollment.
- •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 or grade 2 toxicities well managed with optimal medical care) 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 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/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN
- •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.
排除标准
- •Evidence of biopsy-proven distant metastatic disease after completion of standard treatment
- •Current use of anti-platelet drugs (ASA, 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
- •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.
研究组 & 干预措施
Group 1 (ifetroban)
Experimental
ifetroban capsule (250mg) will be taken by mouth daily.
干预措施: Ifetroban Sodium (Drug)
Group 2 (placebo)
Placebo Comparator
Placebo capsule (250mg) will be taken by mouth daily.
干预措施: Placebo (Other)
结局指标
主要结局
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).
时间窗: Up to 12 months
Summarized change of FACT-G score (scale = 0 to 4)
时间窗: Up to 12 months
Incidence of adverse events
时间窗: Up to 30 days after completing treatment
次要结局
- Percentage of patients within metastatic recurrence (within each cohort)(At 12 months)
- Event-free survival (within each cohort)(Up to 12 months)
研究者
Sonya Reid
Principal Investigator
Vanderbilt-Ingram Cancer Center
研究点 (1)
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