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临床试验/EUCTR2019-004991-20-ES
EUCTR2019-004991-20-ES进行中（未招募）1 期

A phase II triAl of Cabozantinib for hepaTocellular carcInoma patients intOlerant to sorafenib treatment or first line treatment different to sorafeNib. (ACTION trial)

Fundació Clinic per a la Recerca Biomèdica0 个研究点目标入组 40 人开始时间: 2020年2月21日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
40
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. HCC diagnosed according to American Association for the Study of Liver Diseases (AASLD) guideline.
  • •2. Intolerant to sorafenib according to RESORCE trial definition or patients who received treatment different to sorafenib as first-Line treatment (lenvatinib or atezolizumab bevacizumab).
  • •3. The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation)
  • •4. Recovery to = Grade 1 according to (CTCAE) v.5.0. from toxicities related to any prior treatments, unless the adverse events are clinically non-significant and/or stable on supportive therapy
  • •5. Respect the 15 days of first-line treatment washout before starting cabozantinib
  • •6. Age = 18 years old on the day of consent
  • •7. ECOG performance status of 0 or 1
  • •8. Adequate hematologic function, based upon meeting the following laboratory criteria within
  • •7 days before starting therapy:
  • •a. absolute neutrophil count (ANC) = 1200/mm3 (= 1.2 x 109/L)
  • •b. platelets = 60,000/mm3 (= 60 x 109/L)
  • •c. hemoglobin = 8 g/dL (= 80 g/L)
  • •9. Adequate renal function, based upon meeting the following laboratory criteria within 7 days before starting therapy:
  • •a. Serum creatinine = 1.5 × upper limit of normal or calculated creatinine clearance
  • •= 40 mL/min (using the Cockroft-Gault equation: (140 – age) x weight (kg)/(serum Creatinine x72 [mg/dL]) for males. (For females multiply by 0.85).
  • •b. Urine protein/creatinine ratio (UPCR) = 1 mg/mg (= 113.1 mg/mmol) or 24-hour urine protein < 1 g
  • •10. Child-Pugh Score of A
  • •11. Total bilirubin = 2 mg/dL (= 34.2 µmol/L) within 7 days before starting therapy
  • •12. Serum albumin = 2.8 g/dL (=28 g/L) within 7 days before starting therapy
  • •13. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5.0 upper limit of
  • •normal (ULN) within 7 days before starting therapy
  • •14. Hemoglobin A1c (HbA1c) = 8% within 28 days before starting therapy (if HbA1c results are
  • •unavailable [eg, hemoglobin variant], a fasting serum glucose = 160 mg/dL)
  • •15. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection
  • •16. Capable of understanding and complying with the protocol requirements and signed informed consent
  • •17. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, 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
  • •18. Female subjects of childbearing potential must not be pregnant at screening. Females of
  • •childbearing potential are defined as premenopausal females capable of becoming pregnant
  • •(ie, females who have had any evidence of menses in the past 12 months, with the exception
  • •of those who had prior hysterectomy). However, women who have been amenorrheic for 12
  • •or more months are still considered to be of childbearing potential if the amenorrhea is
  • •possibly due to prior chemotherapy, antiestrogens, ovarian suppression, low body weight,
  • •or other reasons.
  • •19. Subjects must consent to perform a tumor biopsy within 4 weeks before starting cabozantinib, allowing the acquisition of a tumor sample for performance of correlative studies. A formalin-fixed, paraffin embedded (FFPE) tumor tissue block of tumor sample should be stored at local sites for correlative studies. For these biopsies, subjects must have a soft tissue tumor lesion that can be biopsied at acceptable clinical risk, as judged by the invest

排除标准

  • •1.Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
  • •2.Radiation therapy (eg, I-131 or Y-90) within 4 weeks (2 weeks for radiation for bone metastases or radionuclide treatment within 6 weeks of starting therapy (subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy)
  • •3.Prior cabozantinib treatment
  • •4.Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before starting therapy. Eligible subjects must be without corticosteroid treatment at the time of starting therapy.
  • •5.Concomitant anticoagulation, at therapeutic doses. Low dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (= 1 mg/day), and low dose LMWH are permitted.
  • •6.The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions
  • •a.Cardiovascular disorders
  • •b.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 (eg, Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
  • •ii.Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before starting therapy
  • •iii.Note: Complete healing of an intra-abdominal abscess must be confirmed prior to starting therapy
  • •c.Major surgery within 2 months before starting therapy. Complete healing from major surgery must have occurred 1 month before starting therapy. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before starting therapy. Subjects with clinically relevant complications from prior surgery are not eligible
  • •d.Cavitating pulmonary lesion(s) or endobronchial disease
  • •e.Lesion invading a major blood vessel
  • •f.including, but not limited to: inferior vena cava, pulmonary artery, or aorta). Subjects with lesions invading the portal vasculature are eligible.
  • •g.Clinically significant bleeding risk including the following within 3 months of starting therapy: hematuria, hematemesis, hemoptysis of >0.5 teaspoon (>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors
  • •h.Other clinically significant disorderssuch as:
  • •i.Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related illness. Subjects with active hepatitis virus infection controlled with antiviral therapy are eligible.
  • •ii.Serious non-healing wound/ulcer/bone fracture
  • •iii.Malabsorption syndrome
  • •iv.Uncompensated/symptomatic hypothyroidism
  • •v.Requirement for hemodialysis or peritoneal dialysis
  • •vi.History of solid organ transplantation
  • •7.Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
  • •8.Moderate or severe ascites
  • •9.Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 7 days before starting therapy
  • •10.Inability to swallow tablets
  • •11.Previously identified allergy or hypersensitivity to components of the study treatment

研究者

发起方
Fundació Clinic per a la Recerca Biomèdica

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