A phase IV, open-label, multi-cohort study to evaluate the safety and tolerability of oral Entrectinib in Indian patients with unresectable, locally advanced or metastatic solid tumors harboring specific oncogenic genomic alterations.
概览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Roche Products (India) Pvt. Ltd
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- This study will evaluate the safety and tolerability of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations
概览
简要总结
This is a Phase IV, open-label, multi-cohort study in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations. The purpose of this study is to assess the safety and tolerability of entrectinib in Indian patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations. Entrectinib has been approved in India by the regulatory agency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Potential patients are eligible to be included in the study only if all of the following criteria apply: 1.Age more than equal to 18 years at the time of signing Informed Consent Form
- •Ability to comply with the study protocol, in the investigator’s judgment
- •Ability to swallow entrectinib intact without chewing, crushing, or opening the capsules
- •Patient has a positive benefit/risk profile for treatment with entrectinib by the investigator.
- •COHORT A (ROS1-POSITIVE NSCLC) SPECIFIC INCLUSION CRITERIA:
- •Histologically- or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C, not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.
- •Documented positivity for ROS1 gene rearrangements must have been determined locally at CLIA-certified or equivalently accredited diagnostic laboratories using nucleic acid-based testing methods that rely on direct assessment of ROS1 gene rearrangements in tumor tissue.
- •Examples of acceptable methods include NGS, Sanger sequencing, reverse transcriptase-polymerase chain reaction, NanoString and EdgeSeq.
- •Fluorescence in situ hybridization is also an acceptable method, with ROS1 positivity, defined as the detection of at least 15 percent of neoplastic nuclei with ROS1 gene rearrangements among a minimum of 50 total neoplastic nuclei.
- •Immunohistochemistry is not an acceptable method.
排除标准
- •Potential patients are excluded from the study if any of the following criteria apply:
- •Patients unable to provide consent
- •Patient is not eligible as per local PI and investigators discretion.
结局指标
主要结局
This study will evaluate the safety and tolerability of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations
时间窗: Primary endpoint- | Incidence and severity of adverse events AEs with severity determined according to NCI CTCAE v5 grading scale | Secondary endpoints- | Incidence of SAEs, adverse events of special interest AESIs, greater than equal to Grade 3 AEs, AEs leading to discontinuation of treatment, AEs leading to dose reduction, AEs leading to drug interruption, AEs leading to death
次要结局
- To evaluate the efficacy of entrectinib in patients with unresectable, locally advanced, or metastatic solid tumors harboring specific oncogenic genomic alterations.(Objective ORR, defined as the proportion of participants with a CR or PR on two consecutive occasions 4 weeks apart, as determined by the investigator according to RECIST v1.1. DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. Duration of Treatment)