Phase 1/2, Open-Label, Single-Arm Safety and Efficacy Dose-Finding, Systemic Exposure, and Device Technical Effects of PRV111 (Cisplatin Transmucosal System) in Subjects With Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities
研究概览
简要总结
Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection.
Funding Source: FDA OOPD
详细描述
Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer and 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects were followed for 6 months for disease recurrence.
Ten subjects were enrolled in the study. Up to 21 additional subjects could have been enrolled in Stage 2, if safety and efficacy endpoints were not met. The dose was not changed. All subjects were followed for 6 months post-surgery for disease recurrence.
During and at the conclusion of the treatment period, subjects were monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed T1 (<2 cm) or T2 (>2 cm but < or = 4 cm) squamous cell carcinoma (SCC) of the lip or oral cavity (anterior 2/3 of the tongue, floor of mouth, lower and upper gingiva, salivary gland, hard palate, and buccal mucosa).
- •Tumor must be easily accessible, with no evidence of infection or active bleeding, encroaching major vessels or clinical evidence of neural invasion. Not previously irradiated.
- •Tumors must be amenable to surgical resection no later than 21 days post Visit
- •Clinically or radiologically measurable tumor.
- •ECOG Performance Status of < or =
- •Adequate renal function as demonstrated by renal creatinine clearance.
- •Adequate organ function as assessed by safety labs.
- •Agree to use effective contraception for 30 days after the last dose of study drug.
- •Absence of any serious medical conditions that would impair the subject's ability to participate.
- •Willing and able to provide written informed consent.
- •Able to return to the study site for treatment and follow-up visits as defined in the protocol.
排除标准
- •Known distal metastasis of the SCC of the oral cavity.
- •Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.
- •Concurrent documented malignancy, with the exception of localized SCC of the skin.
- •Exposure to any investigational agent within 3 months prior to screening.
- •Known allergy or hypersensitivity to platinum-containing agents.
- •Active, uncontrolled infection requiring systemic therapy.
- •Known or suspected pregnancy, planned pregnancy or lactation.
研究组 & 干预措施
Open-Label, Single Arm Study of PRV111
Subjects received 3 treatment applications of PRV111 (Cisplatin Transmucosal System) at each of the 4 planned visits within 3 weeks prior to their tumor surgery.
干预措施: PRV111 (Cisplatin Transmucosal System) (Drug)
结局指标
主要结局
Determine a Safe Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Dose-Limiting Toxicities
时间窗: 4 treatment visits in the 21 days prior to surgery
The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of reported dose-limiting toxicities during the PRV111 treatment period
Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses
时间窗: Subjects were evaluated for efficacy during the 4 treatment visits in the 21 days prior to surgery
The starting dose was 1.5 mg/cm2 of cisplatin. Based on the incidence of dose-limiting toxicities and tumor response, subjects would either continue to receive the starting dose or the dose would be de-escalated to 1.0 mg/cm2 or escalated to 2.5 mg/cm2. This measures presents the number of tumor responses during the PRV111 treatment period
次要结局
- Number of Loco-regional Recurrences(Assessed 1, 3 and 6 months post surgery)
- Tumor and Lymph Node (if Available) Platinum Levels(21 days from baseline through surgical excision of the tumor)
- Technical Success - Residual Cisplatin Levels Post-application(4 treatment visits in the 21 days prior to surgery)
- Tumor Response (Tumor Volume Change From Baseline and Pre-op Visit, Approximately 21 Days Prior to Surgical Excision of the Tumor)(Assessed within the 21 days prior to surgical excision of the tumor)
- Systemic Platinum Levels (Cmax)(Cmax is a single value of the highest concentration of platinum in the blood reported from samples taken post-dose across all 4 treatment visits (Baseline [0], 30, 60, and 120 minutes at Visits 1-4))