A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy

Heron Therapeutics2 个研究点分布在 1 个国家目标入组 300 人2022年7月6日

适应症Chemotherapy-Induced Nausea and Vomiting (CINV)

干预措施SUSTOL

概览

阶段: 4 期
干预措施: SUSTOL
疾病 / 适应症: Chemotherapy-Induced Nausea and Vomiting (CINV)
发起方: Heron Therapeutics
入组人数: 300
试验地点: 2
主要终点: Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL.
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy [MEC] or Anthracycline and Cyclophosphamide [AC] combination regimen).

注册库

clinicaltrials.gov

开始日期

2022年7月6日

结束日期

2025年10月

最后更新

2年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Heron Therapeutics

责任方

Sponsor

入排标准

入选标准

•Has cancer and is scheduled to receive MEC or AC regimen for at least 4 cycles of chemotherapy, and is prescribed SUSTOL for CINV prevention.
•Has an Eastern Cooperative Oncology Group performance status of 0 or
•Has life expectancy of greater than 6 months.
•Able to receive standardized doses of dexamethasone for the prevention of emesis.
•Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

排除标准

•Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists.
•Severe renal impairment (creatinine clearance \[CLcr\] \<30 mL/min).
•Symptomatic primary or metastatic central nervous system (CNS) disease.
•Has participated in an interventional clinical study within 30 days of Cycle 1 Day
•Investigator assessment that subject would not be a good fit for the trial.