EUCTR2018-002820-18-FR进行中（未招募）1 期
A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS - CABOPOINT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 250
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) Subjects must provide a signed informed consent prior to any study-related procedures;
- •(2) Male or female subjects must be aged =18 years on the day the informed consent is signed;
- •(3)Subjects must have histologically confirmed unresectable, locally advanced (defined as disease not eligible for curative surgery or radiation therapy) or metastatic RCC with a clear-cell carcinoma component;
- •(4) Subjects must have radiographic disease progression, according to Investigator’s judgement, following 1st line treatment with CPI (ipilimumab plus nivolumab) (Cohort A) or CPI in combination with VEGF-targeted therapy (Cohort B);
- •(5) Subjects present =1 target lesion according to RECIST 1.1 per investigator;
- •(6)Subjects should have Eastern Cooperative Oncology Group (ECOG) status 0-1;
- •(7) Subjects with treated brain metastases are eligible if metastases have been shown to be stable as per Investigator’s judgement;
- •(8) Subjects must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 10 days before study entry:
- •(a)Absolute neutrophil count (ANC) = 1500/mm3 (= 1.5 GI/L).
- •(b) Platelets = 100,000/mm3 (= 100 GI/L).
- •(c) Hemoglobin = 9 g/dL (= 90 g/L).
- •(d) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
- •(e) Total bilirubin = 1.5 × the upper limit of normal. For subjects with Gilbert’s disease = 3 mg/dL (= 51.3 µmol/L).
- •(f) Fasting serum triglycerides = 2.5 × upper limit of normal AND total cholesterol = 300 mg/dL (= 7.75 mmol/L). Lipid-lowering medication is allowed.
- •(g) Serum creatinine = 2.0 × upper limit of normal or calculated creatinine clearance = 30 mL/min (= 0.5 mL/sec) using the Cockroft-Gault equation
- •(h) Urine protein-to-creatinine ratio (UPCR) = 1 mg/mg (= 113.2 mg/mmol) creatinine or 24-hour urine protein < 1 g.
- •(9) Subject must have recovered to baseline or = Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy as determined by the investigator;
- •(10) Subjects must have completed a steroid taper, if he/she must have had an immune-related adverse event associated with immune CPI;
- •(11) Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) must provide a negative pregnancy test within 7 days prior to the start of study treatment. If a urine test cannot be confirmed as negative, a negative serum pregnancy test is required;
- •(12) Female subjects of childbearing potential (i.e. less than or equal to 2 years post-menopause and not surgically sterile) must agree to use medically accepted methods of contraception (e.g. barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment;
- •(13) All male participants must agree to refrain from donating sperm and unprotected sexual intercourse with female partners during the study and for 120 days after the last dose of study treatment;
- •(14)Subjects must be willing and able to comply with study requirements, remain at the investigational site for the required duration of each study visit and be willing to return to the investigational site for the follow up evaluation, as specified in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •(1) diagnosis of predominant non clear cell RCC;
- •(2)Inability to swallow tablets or capsules;
- •(3)treated with any other investigational medicinal product (IMP) within the last 30 days before study entry;
- •(4) previously treated with cabozantinib;
- •(5)Presents untreated brain or leptomeningeal metastases, or current clinical or radiological progression of known brain metastases;
- •(6)diagnosis of a serious cardiovascular disorder:
- •(a)Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, or serious cardiac arrhythmias;
- •(b)Uncontrolled hypertension, defined as sustained blood pressure (BP) (>140 mm Hg systolic or >90 mm Hg diastolic pressure) despite optimal antihypertensive treatment;
- •(c)Stroke (including transient ischaemic attack (TIA)), myocardial infarction (MI) or other ischaemic event, or thromboembolic event (e.g. deep venous thrombosis, pulmonary embolism) within 6 months before study entry;
- •(d)History of risk factors for torsades de pointes (eg, long QT syndrome);
- •(7) receiving a concomitant anticoagulation with oral anticoagulants (e.g. warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors
- •Note: Low dose aspirin for cardioprotection, low dose warfarin (<1 mg/day), and low dose, (LMWH) are permitted.
- •(8)gastrointestinal (GI) disorder including those associated with a high risk of perforation or fistula formation:
- •(a)Tumours invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction;
- •(b)Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before study entry;
- •Note: Complete healing of an intra-abdominal abscess must have been confirmed before study entry.
- •(9)Presents a corrected QT (QTc) interval calculated by the Fridericia formula (QTcF) > 500 msec within 1 month prior to study entry;
- •Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility
- •(10) clinically significant haematuria, hematemesis, or haemoptysis of >0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding within 3 months before study entry;
- •(11) cavitating pulmonary lesion(s) or known endobronchial disease manifestation;
- •(12) lesions invading major pulmonary blood vessels;
- •(13) diagnosed with other clinically significant disorders such as:
- •(a)Serious nonhealing wound/ulcer/bone fracture;
- •(b)Malabsorption syndrome;
- •(c)Free thyroxine (FT4) outside the laboratory normal reference range;
- •(d)Uncompensated/symptomatic hypothyroidism;
- •(e)Moderate to severe hepatic impairment
- •(f)Requirement for haemodialysis or peritoneal dialysis
- •(g)History of solid organ transplantation;
- •(14)predicted life expectancy of less than 3 months;
- •(15)prior surgery within 4 weeks prior to study entry. Note: If the subject has undergone major surgery, complete wound healing must have occurred 1 month prior to study entry.
- •(16) palliative radiation therapy for bone within 2 weeks or for radiation fields including viscera within 4 weeks prior to study entry. Note: Resolution/healing of side effects must be complete within 4 weeks prior to study entry;
- •(17) history of
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