Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Participants Experiencing Adverse Events
研究概览
简要总结
The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.
Patients will be treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.
详细描述
This is a phase 2 window of opportunity trial in patients with locally advanced head and neck cancer. A key objective is to provide the first proof that macrophage phenotype switching can be accomplished in humans and lay the groundwork for future trials of this novel approach to immune therapy. Patients who are candidates for surgical resection will be enrolled and treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.
The study team hypothesizes that mRNA signatures of immune response will be increased in IPI-549-treated patients. For the efficacy endpoints, RECISTv1.1 will be used.
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
- •Have locally advanced that is amenable to surgical resection
- •Must be able to swallow tablets
- •Must be able to undergo a core tumor biopsy.
- •Must have adequate organ function.
排除标准
- •Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer.
- •Planned major surgery within 4 weeks prior to initiation of study drug
- •Patients treated with chemotherapy, biologic therapy, or other investigational agent within < 28 days of starting study drug
- •History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV)
- •On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids
- •Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy)
- •Female subjects who are pregnant or breastfeeding
- •Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
研究组 & 干预措施
Arm A: IPI-549 40 mg PO qdaily
Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days
干预措施: IPI-549 (Drug)
结局指标
主要结局
Participants Experiencing Adverse Events
时间窗: 7 weeks
To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.
次要结局
未报告次要终点
研究者
Assuntina G. Sacco, MD
Professor of Medicine
University of California, San Diego