NCT05200650招募中1 期
A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor
IntraGel Therapeutics1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of Serious Adverse Events
研究概览
简要总结
IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 18-80 years.
- •Subjects who are willing to comply with study procedures.
- •Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
- •Subjects with a known diagnosis of primary head and neck cancer, with or without metastases.
- •Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
- •Subjects with a measurable tumor by either ultrasound, MRI or CT.
- •Subjects with ECOG performance status of 0 -2.
排除标准
- •Subjects with life expectancy of less than 3 months.
- •Pregnant or breastfeeding women.
- •Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV<50% predicted for age.
- •Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance < 40 ml/min, calculated by using the Cockroft and Gault formula.
- •Reduced hepatic function, defined as ASAT, ALAT, bilirubin > 1.5xULN and PK-INR > 1.5, or a known medical history of liver cirrhosis or portal hypertension.
- •Blood leukocytes count <1.5 *103/microl or platelets <75 *103/microl.
- •Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.
- •Participation in any other clinical trial that included an investigational device or medicinal product.
- •Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
结局指标
主要结局
Rate of Serious Adverse Events
时间窗: 90 days
Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)
次要结局
- Change in Tumor Size (Efficacy)(90 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell CarcinomaMerkel Cell CarcinomaNCT02035657Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)10
已完成
不适用
MitraClip China PMSMitral RegurgitationNCT04259411Abbott Medical Devices51
已完成
1 期
A Study on the Effects of Repeat Doses of Intraject® Sumatriptan on Local Site SignsHealthyNCT00620425Zogenix, Inc.18
尚未招募
不适用
Safety and Performance of PTMC Dermal FillerModerate to Severe Nasolabial FoldNCT06316479Aqpha Medical B.V.120
已完成
2 期
Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With ChemotherapyCarcinoma, Non-Small-Cell LungNCT01022671Chong Kun Dang Pharmaceutical52