An investigator-initiated POC Ph 2 study to evaluate the safety and efficacy of VT-1953 topical gel in advanced cancer patients with malodorous malignant fungating wounds.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint:
研究概览
简要总结
This is an open label, investigator-initiated study to evaluate the efficacy and safety of VT-1953 Topical Gel in advanced cancer patients with malodorous malignant fungating wounds.
First 10 patients will receive VT-1953 while next 5 patients will receive Vehicle control. All subjects will be treated twice daily (BID) for 2 weeks.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 9.00 Day(s) 至 75.00 Day(s)（—）
- 性别
- All
入选标准
- •1 Male or female subjects aged above 9 years old with a diagnosis of malodorous malignant fungating wound malodor corresponding to 0,1 and 2 on the TELER odor scale where 0 Malodor detected upon entering room above 3m or above 10ft with dressing on 1 Malodor detected at above 2m above 3m between 6 to 10ft distance from patient with dressing on and 2 Malodor detected at 1m or arm s length to the patient with dressing on, as judged by the investigators 2 Signed informed consent for adults For subjects under 16 years of age a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form or equivalent if applicable, approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC) Whenever practical and appropriate per local requirements a child’s assent should also be sought before inclusion into the study 3 An Eastern Cooperative Oncology Group (ECOG) performance status of ≤3; 4 An anticipated survival of above 3 months.
排除标准
- •5 Patients who are likely to respond to chemotherapy or radiation therapy.
- •6 Patients with current bleeding in wounds.
- •7 Subjects currently being treated with any antibiotic for bacterial infections or suffering from any infection that may require systemic antibiotic.
- •8 Patient is above 9 years of age at the time of informed consent 9 Life expectancy of below 3 months.
- •10 The patient is not an appropriate candidate for participation in this clinical study for any other reason as deemed by the investigator.
- •11 Subjects with known hypersensitivity to fluoroquinolones 12 Patients with serious cardiovascular diseases hemodyscrasia predisposition to arrhythmias (eg QT-interval prolongation, uncorrected hypokalemia or hypomagnesemia, significant bradycardia) 13 Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol 14 Nursing mothers pregnant women.
结局指标
主要结局
Primary Efficacy Endpoint:
时间窗: Primary Efficacy Endpoint: | 1. Mean score of malodor associated with malignant fungating | wounds (scored by investigators) using a 6 point TELER | Scale on Day 14.
1. Mean score of malodor associated with malignant fungating
时间窗: Primary Efficacy Endpoint: | 1. Mean score of malodor associated with malignant fungating | wounds (scored by investigators) using a 6 point TELER | Scale on Day 14.
wounds (scored by investigators) using a 6 point TELER
时间窗: Primary Efficacy Endpoint: | 1. Mean score of malodor associated with malignant fungating | wounds (scored by investigators) using a 6 point TELER | Scale on Day 14.
Scale on Day 14.
时间窗: Primary Efficacy Endpoint: | 1. Mean score of malodor associated with malignant fungating | wounds (scored by investigators) using a 6 point TELER | Scale on Day 14.
次要结局
- Key Secondary Efficacy Endpoints:(5. Mean score of malodor scored by the patient at Day 7 and 14)
研究者
Dr Prashant P Lad
Om Sai onco Surgery Center .