EUCTR2020-001898-78-IT进行中（未招募）1 期
A Phase II Single Arm Interventional Trial Evaluating the Activity and Safety of combination between Cabozantinib and Temozolomide in Lung and GEP-NENs progressive after SSAr, everolimus, sunitinib or PRRT. - CABOTEM
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
- 35
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
- •1.18 years and older patients
- •2.Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient’s awareness and willingness to comply with the study requirements.
- •3.Documented histological or cytological diagnosis of well differentiated Lung and GEP-NENs (NET G1, NET G2, NET G3 in WHO 2017 classification) progressing after a first line of therapy with SSAs, sunitinib, everolimus, chemotherapy and/or PRRT or documented histological or cytological diagnosis of Large cells neuroendocrine carcinoma patients with Ki67< 55% progressed after platinum-based first line chemotherapy.
- •4.Subjects must have evidence of progressed disease, radiologically documented in the 12 months previous study entry.
- •5.Subjects must have evidence of measurable disease as determined by the investigator. Target lesions must have shown evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria in the 12 months prior to study entry. Patients must have measurable disease per RECIST 1.1 by computer tomography (CT) scan or magnetic resonance imaging (MRI). Gallium 68 PET Scan can be considered useful before and during the treatment.
- •6.Subjects with functional (associated with a clinical hormone syndrome) and non functional tumors are eligible for the study.
- •7.The concurrent use of somatostatin analogues is allowed provided that the patient has been on a stable dose for at least two months.
- •8.At least 4 weeks of wash-out from previous targeted therapies.
- •9.At least 6 months of wash-out from previous PRRT treatment.
- •10.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- •11.Subjects must have adequate organ function, including the following:
- •-Bone marrow reserve consistent with: absolute neutrophil count (ANC) =1.5 x109/L; platelet count = 100 x 109/L; haemoglobin = 9 g/dL;
- •-Hepatic: total bilirubin = 1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase [AST/SGOT] and alanine aminotransferase/serum glutamic pyruvic transaminase [ALT/SGPT]) = 2.5 x ULN (< 5 x ULN if liver metastases are present);
- •-Renal: normal serum creatinine or calculated creatinine clearance = 60 mL/min (Cockroft-Gault formula);
- •12.Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- •13.Estimated life expectancy of =12 weeks.
- •14.Sexually active fertile subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
- •15.For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration;
- •16.Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures and willingness to comply with the study requirements.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Receipt of any type of anticancer therapy within 4 weeks before study entry.
- •2.Previous treatment with Temozolomide or cabozantinib
- •3.Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before recruitment.
- •4. Previous PRRT treatment: Systemic treatment with radionuclides within 6 months before study entry.
- •5.Subjects with clinically relevant ongoing complications from prior radiation therapy and/or surgery are not eligible.
- •6.Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before study entry
- •7.Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
- •8.Chronic treatment with corticosteroids or other immuno-suppressive agents.
- •9.Serious illness other than cancer:
- •a.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 recruitment. Note: Complete healing of an intra-abdominal abscess must be confirmed prior to recruitment.
- •b.Cavitating pulmonary lesion(s) or endobronchial disease
- •c.Lesion invading a major blood vessel including, but not limited to: inferior vena cava, pulmonary artery, or aorta. Subjects with lesions invading the portal vasculature are eligible.
- •d.Clinically significant bleeding risk including the following within 3 months of recruitment: 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
- •e.Other clinically significant disorders such as:
- •i.Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related illness.
- •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
- •4.Uncontrolled congestive heart failure (NYHA II, III, IV). Patients with history of congestive heart failure who do not violate this exclusion criterion will undergo an evaluation of their cardiac ejection fraction prior to recruitment, preferably via gated equilibrium radionuclide ventriculography. The results from an earlier assessment (not exceeding 30 days prior to recruitment) may substitute the evaluation at the discretion of the Investigator, if no clinical worsening is noted. The patient’s measured cardiac ejection fraction in these patients must be >40% before recruitment.
- •5.QTcF > 470 msec for females and QTcF > 450 msec for males or congenital long QT syndrome.
- •6.Patients with rare hereditary problems of galattose intolerance, congenital lactase deficiency or glucose-galattose malabsorption.
- •7.Major surgery within 3 months before study entry. Complete wound healing from major surgery must have occurred 1 month before study entry and from minor surge
研究者
相似试验
进行中（未招募）
1 期
A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study) - Alcantara StudyAdult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALLMedDRA version: 16.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 16.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864EUCTR2013-000706-36-ITAmgen Inc.45
进行中（未招募）
1 期
Clinical Phase 2 Study to evaluate the efficacy of the bispecific antibody blinatumomab in adult subjects with Philadelphia Positive Acute Lymphoblastic Leukemia (PH+ ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy.Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALLMedDRA version: 19.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 19.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864EUCTR2013-000706-36-GBAmgen Inc.45
进行中（未招募）
1 期
Clinical Phase 2 Study to evaluate the efficacy of the bispecific antibody blinatumomab in adult subjects with Philadelphia Positive Acute Lymphoblastic Leukemia (PH+ ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy.Adult patients with relapsed and/or refractory Philadelphia Chromosome- positive B-precursor ALLMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000012958MedDRA version: 20.0Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000012975EUCTR2013-000706-36-DEAmgen Inc.41
进行中（未招募）
1 期
A Phase II Single Arm Trial Evaluating the Efficacy and Safety of Temozolomide for Second-Line Treatment of Neuroendocrine Carcinomas Progressing after First-Line Platinum- based TherapyEUCTR2016-005238-31-ITISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE25
进行中（未招募）
1 期
A Phase II Single Arm Trial Evaluating the Efficacy and Safety of Eribulin in Combination With Bevacizumab for Second-Line Treatment of Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer Progressing after First-Line Therapy With Bevacizumab and PaclitaxelEUCTR2013-003194-10-ITConsorzio Oncotech61