A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of Catheter-associated Thrombosis (CAT)
研究概览
简要总结
This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy. Many patients with cancer develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Xisomab 3G3 is type of drug called a monoclonal antibody that may prevent blood clots caused by a catheter in patients receiving chemotherapy.
详细描述
PRIMARY OBJECTIVE I. To determine the efficacy of xisomab as measured by the incidence of catheter-associated thrombosis (CAT) in individuals with a central venous catheter.
SECONDARY OBJECTIVE:
I. To evaluate the safety and tolerability of xisomab 3G3 in cancer patients with a PICC or indwelling catheter.
EXPLORATORY OBJECTIVE:
I. Assessment of drug exposure and catheter occlusions leading to medical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed
- •In consultation with principal investigator (PI) and treating physician, participant's cancer-directed therapy allows for a 1-day period between administration of study drug and subsequent start of planned cancer-directed therapy
- •Individuals with a confirmed solid malignancy that are scheduled to undergo insertion of a PICC line or indwelling central venous catheter as part of planned anticancer therapy per institutional standards
- •Must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Platelet count > 100 x 10^9/L
- •Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal
- •Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
- •Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
排除标准
- •Actively receiving treatment in another therapeutic clinical trial
- •Active acute leukemia (lymphoma and myeloma are allowed)
- •At time of enrollment, known contraindication to anticoagulation therapy, including:
- •Clinically significant active bleeding
- •Individual is within 72 hours of major surgery
- •Abnormal baseline coagulation tests, including international normalized ratio (INR) > 1.5, or activated partial thromboplastin time (aPTT) prolonged
- •Abnormal renal function defined by an estimated glomerular filtration rate (eGFR) < 45 mL/min
- •Abnormal hepatic function defined as liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT] or total bilirubin) > 2 x the upper limit of normal or known Child-Pugh class B or C cirrhosis
- •Prior history of intracranial hemorrhage
- •Primary brain tumors or known brain metastasis
- •Major extracranial bleed within the last 6 months where the cause has not been identified or treated
- •Known bleeding diathesis
- •Use of therapeutic anticoagulation or anti-platelet agents for any indication at enrollment
- •At the discretion of the investigator, any other contraindication to anticoagulation therapy
- •Presence of a pediatric-sized PICC line
- •Participant is expected to receive chemotherapy associated with a 15% or higher incidence of grade 3-4 thrombocytopenia within 14 days of receiving study drug
- •Preexisting intravenous catheter, or indwelling spinal or epidural catheter, at time of enrollment that is intended to remain for the duration of study. Participants may remain eligible if existing catheter is to be removed before placement of a catheter for cancer directed therapy. Removal of existing catheter should occur at least 24 hours prior to PICC or indwelling catheter insertion
- •Previously documented hypersensitivity to either the drug or excipients
- •Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements
- •Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment
- •Participant is allergic to heparin or heparin derivatives
- •Participants with a history of venous thromboembolism within the last 3 months
研究组 & 干预措施
Supportive Care (xisomab 3G3)
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
干预措施: Xisomab 3G3 (Drug)
结局指标
主要结局
Incidence of Catheter-associated Thrombosis (CAT)
时间窗: Up to end of treatment visit (day 18)
The incidence of overall CAT (inclusive of both symptomatic and asymptomatic events) will be assessed and reported with 95% confidence interval.
次要结局
- Incidence of Major and Clinically-relevant Bleeding(Up to end of follow-up (60 days from time of administration))
- Incidence of Xisomab 3G3-associated Adverse Events (AEs)(Up to end of follow-up (60 days from time of administration))
研究者
Joseph Shatzel M.D.
Principal Investigator
OHSU Knight Cancer Institute