EUCTR2018-001495-38-ES进行中（未招募）1 期
A Randomized, Phase 3, Double-blind, Placebo-controlled Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 413
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
- •To be enrolled in the study, patients will be required to meet all of the following criteria:
- •1. Patients aged >= 18 years at time of study entry.
- •2. Has histologically confirmed RCC with clear cell component.
- •3. Locally advanced and unresectable or metastatic disease.
- •4. Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.
- •5. Patients must not have had any prior VEGF tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.
- •6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 17.1).
- •7. Has adequate baseline organ function, as demonstrated by the following:
- •Serum creatinine <= 1.5 × institutional upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
- •Serum bilirubin <= 1.5 ×ULN
- •Aspartate aminotransferase and ALT <= 2.5 x institutional ULN (patients with hepatic metastases must have AST/ALT <= 5 × ULN)
- •For patients not taking warfarin or direct thrombin inhibitor: international normalized ratio (INR) <= 1.5 or prothrombin time <= 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time <= 1.5 × ULN. For patients taking warfarin or direct thrombin inhibitor: INR < 3.5
- •Urine protein to creatinine ratio < 1.0
- •8. Has adequate baseline hematologic function, as demonstrated by the following:
- •Absolute neutrophil count (ANC) >=1.5 × 10^9/L
- •Hemoglobin>=8.0 g/dL
- •Platelet count >=100 × 10^9/L
- •9. Has provided signed informed consent before initiation of any study-specific procedures or treatment.
- •10. Must agree to, and be capable of, adhering to the study visit schedule and other protocol requirements, including follow-up for OS.
- •11. Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.
- •12. A female patient is eligible to enter and participate in this study if she is of:
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female patient who:
- •i. Has had a hysterectomy
- •ii. Has had a bilateral oophorectomy (ovariectomy)
- •iii. Has had a bilateral tubal ligation
- •iv. Is postmenopausal
- •b. Childbearing potential, including any female patient who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
- •Complete abstinence from sexual intercourse for 14 days before exposure to investigational product (IP), through the dosing period, and for at least 21 days after the last dose of IP
- •Oral contraceptive, either combined or progestogen alone
- •Injectable progestogen
- •Estrogenic vaginal ring
- •Percutaneous contraceptive patches
- •Intrauterine device or intrauterine system with a documented failure rate of less than 1% per year
- •Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female patient's entry into the study, and this male patient is the sole partner for that patient
- •Double barrier met
排除标准
- •Patients who meet any of the following criteria at Screening will not be enrolled in the study:
- •1. Has persistent clinically significant toxicities (Grade >= 2; per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5) (NCI CTCAE) from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).
- •2. Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated.
- •3. Has had a major surgical procedure 28 days prior to study randomization.
- •4. Active uncontrolled bleeding or bleeding diathesis.
- •5. Clinically significant gastrointestinal abnormalities that may affect absorption of study medications or increase risk of bleeding or perforation, including:
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion(s) at high risk of bleeding or perforation
- •Active inflammatory bowel disease
- •History of intra-abdominal fistula or abscess within 28 days prior to randomization
- •Clinically significant gastrointestinal tract bleeding within 28 days prior to randomization
- •Any prior history of gastrointestinal tract perforation
- •6. Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.
- •7. Poorly controlled hypertension, defined as systolic blood pressure >= 160 or diastolic blood pressure >= 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
- •8. History of any 1 or more of the following conditions within the past 6 months prior to randomization:
- •a. Symptomatic peripheral vascular disease
- •b. Coronary artery bypass graft surgery
- •c. Myocardial infarction or unstable angina
- •d. Cardiac angioplasty or stent placement
- •e. Cerebrovascular accident including transient ischemic attack
- •9. A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization. Patients on chronic stable anticoagulation for a pulmonary embolism and/or deep venous thrombosis diagnosed more than 3 months prior to date of randomization are eligible for study participation.
- •10. Has a QTcF interval > 480 msec.
- •11. New York Heart Association Class III or IV congestive heart failure.
- •12. Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
- •13. Has known positive status for human immunodeficiency virus (HIV) active or chronic hepatitis B or hepatitis C (screening is not required).
- •14. Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
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