Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 72
- 试验地点
- 15
- 主要终点
- progression free survival
研究概览
简要总结
Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).
详细描述
In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion.
ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%.
43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective.
If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising.
The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07.
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
- •Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
- •Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion >10 mm.
- •Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
- •Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
- •Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
- •Euthyroid patient.
- •Hepatic, renal, cardiac and hematology normal functions.
- •Ability to take oral medication.
排除标准
- •Non salivary gland carcinoma (lachrymal gland tumor is excluded).
- •Known or symptomatic cerebral metastasis.
- •Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
- •Presence of uncontrolled infection.
- •Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
- •Stable disease.
- •Corrected QT interval (QTc) >480 msecs using Bazett's formula.
研究组 & 干预措施
pazopanib
Pazopanib per os, 800mg daily until progression
干预措施: pazopanib (Drug)
结局指标
主要结局
progression free survival
时间窗: 6 months
次要结局
未报告次要终点