KCT0006353进行中（未招募）未知
Multicenter, Open-Label, A Phase 2 Study to evaluate the efficacy of Vactosertib in combination with durvalumab (MEDI4736) as a third-line chemotherapy in patients with advanced gastric cancer
ational Cancer Center0 个研究点目标入组 55 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (Ministry of Food and Drug Safety of Korea) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- •2.Age > 19 years at time of study entry.
- •3.Eastern Cooperative Oncology Group (ECOG)) performance status of 0 or 1
- •4.Histologically- or cytologically-confirmed adenocarcinoma in the stomach and gastroesophageal junction that is refractory to = 2 chemotherapy regimens (including adjuvant/neoadjuvant chemotherapy
- •5.Body weight >30 kg (for durvalumab monotherapy or durvalumab +vactosertib
- •6.Adequate normal organ and marrow function as defined below:
- •Haemoglobin =9.0 g/dL
- •Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
- •Platelet count =100 (or 75) x 109/L (>75,000 per mm3)
- •Serum bilirubin =1.5 x institutional upper limit of normal (ULN). ((This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician).).
- •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
- •Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- •Creatinine CL (mL/min)=Weight (kg) x (140 – Age)
- •72 x serum creatinine (mg/dL)
- •Creatinine CL (mL/min)=Weight (kg) x (140 – Age) x 0.85
- •72 x serum creatinine (mg/dL)
- •7.Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- •Women =50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •8.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •9.Must have a life expectancy of at least 12 weeks
- •10.Measurable lesions as defined by RECIST 1.1
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •1.Participation in another clinical study with an investigational product during the last 22 weeks
- •2.Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- •3.Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy including TKIs, tumor embolization, other investigational agent) = 2 weeks prior to the first dose of study drug (= 4 weeks prior to the first dose of study drug for subjects who have received prior monoclonal antibodies or biologic therapy, and within 6 weeks for nitrosourea or mitomycin C).
- •4.Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •a.Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- •b.Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- •5.Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- •6.Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- •7.Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- •8.History of allogenic organ transplantation.
- •9.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- •a.Patients with vitiligo or alopecia
- •b.Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- •c.Any chronic skin condition that does not require systemic therapy
- •d.Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- •e.Patients with celiac disease controlled by diet alone
- •10.Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- •11.History of another primary malignancy except for
- •a.Malignancy treated with curative intent and with no known active disease =33 years before the first dose of IP and of low potential risk for recurrence
- •b.Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •c.Adequately treated car
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