A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib plus Best Supportive Care (BSC) compared to Placebo plus BSC in Patients with Advanced or Metastatic Gastric Cancer (GC)

SK BioPartners, Inc0 个研究点目标入组 459 人开始时间: 2017年12月14日最近更新: 2020年6月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 459

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female at least 18 years old or older.
•2. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
•3. Patients have locally advanced unresectable or metastatic disease that has progressed since last treatment.
•4. One or more measurable or nonmeasurable evaluable lesions per RECIST 1.1.
•5. Patients should have failed or were intolerant to at least two prior lines of standard chemotherapies with each containing one or more of the following agents:
•o Fluoropyrimidine (IV 5-FU, capecitabine, or S-1),
•o platinum (cisplatin or oxaliplatin),
•o taxanes (paclitaxel or docetaxel) or epirubicin,
•o irinotecan,
•o trastuzumab in case of HER2-positive,
•o ramucirumab
•Previous treatments with experimental agents (except experimental antiangiogenic agents) alone or as part of the first three therapy lines are allowed but not mandatory. A maximum number of three prior therapy lines are allowed.
•(For the patients whose disease recurred within 24 weeks from the last dose of adjuvant anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line.)
•6. Disease progression within 6 months after the last treatment.
•7. Patients who have adequate bone-marrow, renal and liver function including;
•a. Hematologic: Absolute neutrophil count = 1,500/mm3, Platelets = 100,000/mm3, Hemoglobin > 9.0 g/dL (Blood transfusion to meet the inclusion criteria within 2 weeks is not allowed.).
•b. Renal: Creatinine clearance (according to Cockcroft-Gault Equation or by 24 hr urine collection) > 50 mL/min and serum creatinine < 1.0 x ULN.
•c. Hepatic: Serum bilirubin < 1.5 x ULN, AST and ALT = 3.0 x ULN (= 5.0 x UNL, if with liver metastasis).
•d. Blood coagulation tests: PTT and INR = 1.5 x ULN and = 1.5 x ULN, respectively.
•e. The patient’s urinary protein should be < 2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria = 2+, then a 24-hour urine or urine protein/creatinine ratio must be collected and must demonstrate < 2 g of protein in 24 hours to allow participation in the study.
•8. Patients whose Eastern Cooperative Oncology Group (ECOG) performance status are evaluated to be = 1.
•9. Expected survival of = 12 weeks, in the opinion of the investigator.
•10. Ability to swallow the investigational product tablets.
•11. Female patients of child-bearing potential must have a negative serum or urine pregnancy test at the Screening Visit. Females must be surgically sterile, postmenopausal for at least 1 year prior to Screening Visit or must be using an acceptable method of birth control ([oral, non-oral or implantable] hormone contraceptives, intrauterine contraceptive device or blockers and spermicides) effectively. Abstinence is not an acceptable method of contraception for the study.
•12. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 99
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 57

排除标准

•1. Malignancies other than adenocarcinoma of the stomach or gastroesophageal junction (including hematologic malignancies) within 3 years.
•(Squamous cell skin cancer or cervical carcinoma in situ which has been cured after treatment and thyroid and prostate cancers which are deemed by the investigator to have little impact on the prognosis will be allowed.)
•2. CNS metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization. Patients are eligible if metastases have been treated and have returned to neurologic baseline or are neurologically stable (except for residual signs or symptoms related to the CNS treatment).
•3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
•4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator’s opinion, could place the subject at risk. Maximum dose of 325 mg/day of aspirin is allowed.
•5. Patients who had therapeutic paracentesis of ascites (> 1L) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (> 1L) within 3 months of starting study treatment.
•6. Previous treatment with Apatinib.
•7. Known hypersensitivity to Apatinib or components of the formulation.
•8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.
•9. Active bacterial infections.
•10. Patients with substance abuse or medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results. Conditions include but are not limited to;
•- Known history of human immunodeficiency virus (HIV) infection.
•- Active or chronic hepatitis B or C infection or requiring treatment with antiviral therapy or prophylactic antiviral unless evidence of viral suppression has been documented and the patient will remain on appropriate antiviral therapy throughout.
•11. Patients who participated, within 4 weeks prior to randomization, or are participating in any other clinical trial.
•12. Pregnant or breast-feeding women.
•13. History of drug or alcohol abuse within past 5 years.
•14. Medical or psychiatric illnesses that, in the investigator’s opinion, may impact the safety of the subject or the objectives of the study.
•15. History of uncontrolled hypertension (Blood pressure = 140/90 mmHg and change in antihypertensive medication within 7 days prior to randomization) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.
•16. Patients who have known history of symptomatic congestive heart failure (New York Heart Association III-IV), symptomatic or poorly controlled cardiac arrhythmia, complete left bundle branch block, bifascicular block, or any clinically significant ST segment and/or T-wave abnormalities, QTcF > 450/470 msec prior to randomization.
•17. Prior major surgery or fracture within 3 weeks prior to randomization or presence of any non-healing wound (procedures such as cathether placement are not

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发起方

SK BioPartners, Inc

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