EUCTR2013-000762-11-DE进行中（未招募）1 期
A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in High Grade Uterine Sarcoma (HGUtS) after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 115 人开始时间: 2014年8月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
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
- Female
入选标准
- •1) At registration:
- •Patients can be registered no earlier than 4 weeks prior to start of the 1st line treatment and no later than 4 weeks after last administration of 1st line treatment.
- •- Patients who are suitable for treatment with doxorubicin +/- ifosfamide and fall within one of the following patient populations:
- •? HGUS, HGESS, HGLMS and HG adenosarcoma
- •? FIGO stage II and stage III : if adjuvant chemotherapy is proposed
- •? FIGO stage IV: if first line chemotherapy is proposed
- •- 1 formalin fixed paraffin embedded block of tumor tissue is sent after registration of a patient. Histological central review is mandatory to confirm histology and grade.
- •- Patients must be at least 18 years old
- •- Before patient registration, written informed consent for central collection of tissue block or slides and any other trial-specific procedures must be obtained
- •2) At Randomization
- •Patients can be randomized within 12 weeks after last administration of 1st line treatment, before the start of protocol treatment
- •- Central pathological confirmation: Histological evidence of HGUS, HGESS, HGLMS and HG adenosarcoma
- •- Non-progressive patients (CR, PR, SD) after first line treatment and at time of randomization.
- •- Patients able to swallow and retain oral tablets.
- •- WHO/ECOG performance status 0-2
- •- Recovery to baseline or = Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are clinically non significant and/or stable on supportive therapy
- •- The subject has organ and marrow function and laboratory values as follows before randomization
- •. Absolute neutrophil count (ANC) = 1500/mm3 without colony stimulating factor support for 7 days
- •. Platelets = 100,000/mm3
- •. Hemoglobin = 9 g/dL
- •. Bilirubin = 1.5 × the upper limit of normal. For subjects with known Gilbert’s disease, bilirubin = 3.0 mg/dL
- •. Serum albumin = 2.8 g/dl
- •. Serum creatinine = 1.5 × the upper limit of normal or creatinine clearance (CrCl) = 50 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72) × 0.85
- •. Alanine aminotransferase and aspartate aminotransferase = 3.0 × the upper limit of normal or = 5.0 x ULN if liver metastases
- •. Lipase < 2.0 × the upper limit of normal and no radiologic or clinical evidence of pancreatitis
- •. Urine Dipstick: If Urine Dipstick = 2+, determine Urine Protein to Creatinine Ratio (UPCR) by quantitative analysis; if UPCR = 1, then a 24-hour urine protein must be assessed. Any patient with protein > 150 mg over 24 hours would not be eligible.
- •. Serum phosphorus, calcium, magnesium and potassium = lower limit of normal
- •. Prothrombin time (PT) or international normalized ratio (INR) = 1.2 × the upper limit of normal
- •- Clinically normal cardiac function based on the institutional lower limit of normal (LVEF assessed by MUGA or ECHO), normal 12 lead ECG (no prolongation of corrected QT interval (QTc) > 500 msecs according to Fridericia's formula) and no history of any one or more of the following cardiovascular conditions within the past 6 months:
- •. Cardiac angioplasty or stenting
- •. Clinically-significant cardiac arrhythmias
- •. Myocardial infarction
- •. Unstable angina
- •. Coronary artery bypass graft surgery
- •. Symptomatic peripheral vascular disease
- •. Class III or IV congestive heart failure, as defined by the New York Heart Association
- •- Minor surgery within 28 days before the first dose of st
排除标准
- •At Registration
- •? The following tumor types are NOT eligible: low-grade ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
- •At randomization
- •- Prior treatment with cabozantinib
- •- history of congenital long QT syndrome
- •- concurrent severe, clinically relevant hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
- •- patient with concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;
- •- concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors
- •- patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6 months, patients who have suffered a deep venous thrombosis or a pulmonary embolism in the past 6 months
- •note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents and remained stable for at least 6 weeks are eligible: subjects with a venous filter are not eligible for this study
- •- Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
- •- known intra-abdominal tumor/metastases invading GI mucosa
- •- active peptic ulcer disease,
- •- inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.
- •- malabsorption syndrome
- •- Ongoing visceral complications from prior therapy
- •- Prior gastrointestinal surgery
- •? Any of the following within 6 months before the first dose of study treatment:
- •- abdominal or vaginal fistula
- •- gastrointestinal perforation
- •- bowel obstruction or gastric outlet obstruction
- •- intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating study treatment even if the abscess occurred more than 6 months before the first dose of study treatment.
- •- clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
- •- patients with evidence of tumor invading the GI tract or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of study treatment
- •- patients with radiographic evidence of cavitating pulmonary lesion
- •- patients with tumor in contact with, invading or encasing any major blood vessels.
- •- patients evidence of tumor invading the GI tract, or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of study trt
- •- evidence of active bleeding or bleeding diathesis.
- •- hemoptysis = 0.5 teaspoon of red blood within 3 months before the first dose of study treatment. Note: Any patient with a prior history of hemoptysis associated with metastatic disease must have a bronchoscopy to rule out endobronchial lesions. A patient with an endobronchial lesion
- •- signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
- •- Major surgery or trauma within 12 weeks prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer. Complete wound healing from major surgery must have occurred one month
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