KCT0003175招募中未知
Phase II, single-arm study of vismodegib in advanced gastric adenocarcinoma patients with SMO overexpression
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Provision of fully informed consent prior to any study specific procedures.
- •2.Patients must be =20 years of age.
- •3.Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after 1st line, second-line or third-line therapy.
- •-Patient must have metastatic, progressive, unresectable diseases which have to be treated by palliative treatment only.
- •-Both fluoropyrimidine and platinum agent need to be contained in the prior chemotherapies
- •-Prior adjuvant or neoadjuvant therapy is counted as 1 regimen, provided that disease progression occurs within 6 months after the completion of adjuvant or neoadjuvant therapy.
- •-Acceptable prior chemotherapy regimens for this protocol are chemotherapy regimens that include Immune Target agent therapy. (such as a pembrolizumab, ramucirumab etc)
- •4.Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •5. Patients with SMO overexpression by IHC However, research can be registered according to the clinical judgment of the Investigator even if there is no excessive expression of SMO.
- •5.Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
- •6.ECOG performance status 0-1.
- •7.Patients must have a life expectancy = 3 months from proposed first dose date.
- •8.Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
- •-Haemoglobin =9.0 g/dL (transfusion allowed)
- •-Absolute neutrophil count (ANC) = 1.5 x 109/L
- •-White blood cells (WBC) > 3 x 109/L
- •-Platelet count =100 x 109/L (transfusion allowed)
- •-Total bilirubin = 1.5 x institutional upper limit of normal (ULN) (does not include patients with Glibert?s disease)
- •-AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be = 5x ULN
- •-Serum creatinine =1.5 x institutional ULN
- •9.Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. for women of childbearing potential.
- •10.Provision of consent for mandatory biopsy at progression (fresh frozen will be mandatory if clinically feasible)
- •11.Provision of archival or fresh tissue sample at baseline (fresh frozen will be mandatory if clinically feasible)
- •a. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
- •b.Collection of an archived tissue sample will also be requested (where available) to support evaluation of the clinical utility of biomarker assessment in newly obtained vs. archived tissue samples; however, a subject will not be precluded from participating in the study if an archived tissue sample is not available for collection or is otherwise insufficient for analysis.
排除标准
- •1.Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •2.Any previous treatment with Hedgehog pathway inhibitor
- •3.Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for =5 years.
- •4.HER2 positive patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)
- •5.Patients unable to swallow orally administered medication.
- •6.Treatment with any investigational product during the last 21 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
- •7.Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 3 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates or denusomab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
- •8.With the exception of alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.
- •9.Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
- •10.Resting ECG with measurable QTcB > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- •11.Patients with cardiac problem as follows: Atrial fibrillation with a ventricular rate >100 bpm on ECG at rest , Symptomatic heart failure (NYHA grade II-IV), Prior or current
- •cardiomyopathy, Severe valvular heart disease, Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy), Acute coronary syndrome within 6 months prior to starting treatment
- •12.Female patients who are breast-feeding or child-bearing and Male or female patients of reproductive potential who are not employing an effective method of contraception
- •13.Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV) (HBV carrier is allowed)
研究者
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