A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 19
- 主要终点
- Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT)
研究概览
简要总结
The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.
Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.
Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets protocol-specified criteria for qualification and contraception
- •Is willing and able to comply with study procedures and restrictions related to food, drink and medications
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
排除标准
- •Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff;
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
- •the analysis of results
研究组 & 干预措施
Debio 1143
In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Cisplatin (Drug)
Debio 1143
In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Radiotherapy (Radiation)
Debio 1143
In addition to Cisplatin and Radiotherapy, Debio 1143 in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Debio 1143 (Drug)
Placebo
In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Cisplatin (Drug)
Placebo
In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Radiotherapy (Radiation)
Placebo
In addition to Cisplatin and Radiotherapy, matching placebo in solution form will be administered orally or by feeding tube (while fasting) daily for 14 days every three weeks (on days 1-14, 22-35 and 43-56).
干预措施: Placebo (Drug)
结局指标
主要结局
Phase II: Percentage of participants achieving Locoregional Control (LRC) at 18 months from the end of chemo-radiation therapy (CRT)
时间窗: within 4 years
次要结局
- Phase II: Best Overall response rate, Disease Control rate and Response Rate after 10 weeks from the end of CRT(within 5 years)
- Phase II: Locoregional control rate at 6 months and one year after completion of CRT(within 5 years)
- Phase II: Progression free survival rate at one year, 18 months and at 2 years as of initiation of CRT(within 5 years)
- Phase II: Distant relapse rate at six months, one year and 18 months after completion of CRT(within 5 years)
- Phase II: Disease specific survival rate one year and at 2 years as of initiation of CRT(within 5 years)
- Phase II: Overall survival rate at one year and at 2 years as of initiation of CRT(within 5 years)
- Phase II: Number of participants with clinically significant change in vital signs during participation in the trial(within 5 years)
- Phase II: Number of participants with Serious Adverse Events(within 5 years)
- Phase II: Number of participants with Adverse Events (AEs)(within 5 years)
- Phase II: Number of participants with Laboratory Abnormalities(within 5 years)
- Phase II: Number of participants with Late Toxicity as of initiation of CRT(within 5 years)
- Phase II: Number of participants with treatment changes due to AEs(within 5 years)
- Phase II: Complete Response Rate (by RECIST version 1.1) at six months after completion of chemo-radiation therapy (CRT) therapy(within 5 years)
- Phase II: Best Overall response rate, Disease Control rate and Response Rate after 6 months from the end of CRT(within 5 years)