EUCTR2018-000363-91-ES进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 444
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. Informed Consent
- •a. Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
- •2. Target Population
- •a. Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
- •b. Age = 18 years
- •c. Karnofsky Performance Score (KPS) = 70% (Attachment 4)
- •d. Estimated Life Expectancy of at least 3 mo
- •e. Measurable Disease per RECIST 1.1 as determined by the Investigator (see Attachment 5)
- •f. One and not more than two prior systemic lines of therapy for advanced or metastatic RCC including at least one anti-angiogenic therapy –OR– the combination regimen of nivolumab + ipilimumab 1) For the most recent anti-angiogenic therapy or nivolumab + ipilimumab, the patient must have had radiographic progression of disease (as determined by the treating physician) either (i) during treatment or (ii) within 6 mo following at least 4 weeks of treatment. 2) The patient must have had radiographic disease progression on the most recent systemic therapy within 6 mo before randomization. 3) Prior treatment with other anticancer therapies including immunotherapy, cytokines, vaccines, monoclonal antibodies, and cytotoxic chemotherapy is allowed.
- •3. Laboratory Findings
- •a. Serum creatinine = 2.0 × upper limit of normal or calculated creatinine clearance (CCr) = 30 mL/min (= 0.5 mL/sec) using the Cockcroft-Gault equation: CCr = {((l40 – age) x actual body weight)/ (72 x SCr)} x 0.85 (if female)
- •b. Adequate hematological function, defined as absolute neutrophil count = 1,500/mm3, hemoglobin = 9.0 g/dL, and platelet count = 100,000/mm3. Transfusions and growth factors must not be used within 2 weeks prior to randomization to meet these requirements.
- •c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3.0 × upper limit of normal.
- •d. Total bilirubin = 1.5 × the upper limit of normal. For patients with Gilbert’s disease, = 3 mg/dL (= 51.3 µmol/L).
- •e. Urine protein-to-creatinine ratio (UPCR) = 1 mg/mg (= 113.2 mg/mmol) creatinine or 24-hour urine protein < 1 g.
- •4. Reproductive Status
- •a.Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the first dose of study drug and if sexually active must agree to use dual methods of contraception during the study and for a minimum of 4 mo following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential and refrain from donating sperm during the study and for a minimum of 4 mo following the last dose of study drug.
- •5. Other Inclusion Criteria
- •a. Recovery to baseline or = Grade 1 CTCAE v.4.0 from toxicities related to any prior cancer therapy, unless after discussion with medical monitor adverse events (AEs) are deemed clinically non-significant and/or stable on supportive therapy.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •Medical History
- •a. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
- •b. Receipt of any anticancer therapy within the following windows before randomization:
- •Small molecule receptor tyrosine kinase inhibitor (TKI) therapy (including investigational) within 2 weeks or 5 half-lives, whichever is longer
- •Any type of anticancer antibody or cytotoxic chemotherapy within 4 weeks
- •Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before randomization. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- •Other investigational therapy within 4 weeks or 5 half-lives, whichever is shorter
- •c. Patients with active and/or untreated central nervous system (CNS) cancer are not eligible. Patients with treated brain metastases (1) must have documented radiographic stability of at least 4 weeks duration demonstrated on baseline contrast-enhanced CNS imaging (e.g., contrast-enhanced MRI of the brain) prior to randomization and (2) must be symptomatically stable and off of steroids for at least 2 weeks before randomization.
- •d. Any other current or previous malignancy within the past three years except:
- •Adequately treated basal cell or squamous cell skin cancer,
- •Carcinoma in situ of the cervix,
- •Prostate cancer with stable prostate specific antigen (PSA) levels for > 3 years, or
- •Other neoplasm that, in the opinion of the Principal Investigator and with the agreement of the Medical Monitor, will not interfere with studyspecific endpoints
- •e. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- •f. Corrected QT interval > 500 msec within 1 month before randomization.
- •2. Concurrent Conditions
- •a. Unable to receive oral medications or any condition that may prevent adequate absorption of oral study medication including refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes
- •b. Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization. Patients with clinically relevant ongoing complications from prior surgery are not eligible.
- •c. The patient has uncontrolled, significant current or recent illness including, but not limited to, the following conditions:
- •Cardiovascular disorders:
- •i. Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias
- •ii. Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment
- •iii. Stroke (including TIA), myocardial infarction, or other ischemic event within 6 mo before randomization, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 mo before randomization
- •Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
- •i. Tumors 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
- •ii. Abdominal fistula, gastroint
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