NL-OMON53073招募中2 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 - Cabozantinib maintenance in HGUtS
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) At registration, - 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, -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., - 1
- •formalin fixed paraffin embedded (FFPE) block of tumor tissue (if not
- •available, at least 1 H/E (haematoxylin/eosin) and 15 unstained slides) 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
- •from the patient according to ICH/GCP, and national/local regulations, allowing
- •for collection, storage and analysis of tissue and screening procedures., 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) at the end of the
- •first line standard chemotherapy (4 to 6 cycles of doxorubicin alone or in
- •combination with ifosfamide)., - Non-progressive patients (CR, PR, SD) at the
- •end of the first line standard chemotherapy (4 to 6 cycles of doxorubicin alone
- •or in combination with ifosfamide)., - 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 nonsignificant 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 (ULN). For subjects with known
- •Gilbert*s disease, bilirubin <= 3.0 mg/dL
- •* Serum albumin >= 2.8 g/dl
- •* Serum creatinine <= 1.5 * ULN or creatinine clearance (CrCl) >= 50 mL/min. For
- •creatinine clearance estimation, the Cockcroft and Gault equation should be
- •CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72) × 0.85
- •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0 *
- •ULN or <= 5.0 x ULN if liver metastases
- •* Lipase < 2.0 x 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 >= LLN
- •* Prothrombin time (PT) or international normalized ratio (INR) * 1.2 X upper
- •limit of normal (ULN), - Clinically normal cardiac function based on the
- •institutional lower limit of normal (LVEF asses
排除标准
- •At randomization, - 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., - No contraindications to cabozantinib (e.g. no known immediate
- •or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically
- •related to cabozantinib), - No planned use of chemotherapy, radiation therapy,
- •radionuclide treatment, small molecule TKI or hormonal therapy, and any other
- •investigational agent during the treatment period., - No prior treatment with
- •cabozantinib, - No concurrent severe, clinically relevant hypothyroidism or
- •thyroid dysfunction within 7 days before the first dose of study treatment, -
- •No 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;,
- •- No concomitant anticoagulation at therapeutic doses with oral anticoagulants
- •(eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors
- •(eg, clopidogrel); , - No 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 (DVT)
- •or a pulmonary embolism in the past 6 months , - No 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 (including ulcerative colitis and 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.
- •* malabsorption syndrome
- •* Ongoing visceral complications from prior therapy
- •* Prior gastrointestinal surgery (particularly when associated with delayed or
- •incomplete healing)
- •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 treatment with Cabozantinib even
- •if the abscess occurred more than 6 months before the first dose of study
- •treatment., - No clinically-significant gastrointestinal bleeding within 6
- •months before the first dose of study treatment, - No patients with evidence of
- •tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum
- •or anus), or any evidence of endotracheal or endobronchial tumor within 28 days
- •before the first dose of study treatment (Cabozantinib/placebo)., - No patients
- •with radiographic evidence of cavitating pulmonary lesion(s)., - No patients
- •with tumor in contact with, invading or encasing any major blood vessels., - No
- •evidence of active bleeding or bleeding diathesis.
- •- No hemoptysis >= 2.5ml of red blood within 3 months before the first dose of
- •study treatment., - No signs indicative of pulmonary hemorrhage within 3 months
- •before the first dose of st
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