EUCTR2017-000607-25-ES进行中（未招募）1 期
An Investigator-Sponsored Randomized Phase III Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer - BGOG-EN5/ENGOT-EN5/SIENDO
ZLEUVEN/BGOG0 个研究点目标入组 161 人开始时间: 2018年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 161
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.Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- •2.Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed.
- •Must have received a paclitaxel-carboplatinum combination in at least one prior therapy.
- •Prior second-line anthracycline based or again paclitaxel-carboplatin is allowed.
- •Prior hormonal treatment is allowed.
- •3. The following patients can be enrolled in the trial:
- •a)Patients with stage IV disease (FIGO 2009), who have completed first-line taxane-carboplatin combination at least 12 weeks and are in partial or complete remission according to RECIST 1.1, or
- •b)Patients who have relapsed after primary therapy and have completed paclitaxel -carboplatin combination for at least 12 weeks (4 cycles of 3-or 4 weekly or 12 courses of weekly) for relapse and are in partial or complete remission according to RECIST 1.1, or
- •c)Patients who have relapsed after primary therapy and have completed a paclitaxel-carboplatin combination and a second-line chemotherapy for at least 12 weeks for relapse and are in partial or complete remission according to RECIST 1.1.
- •Prior adjuvant for Stage I-III is not counted as a line of chemotherapy unless the relapse occurred within 6 months after the last adjuvant course of chemotherapy for stage I-III disease
- •4. Patients must be started on study treatment between 3 and 8 weeks after completion of their final dose of the chemotherapy.
- •5. Patients may have undergone primary surgery. Patients who have had complete cytoreductive surgery (i.e., no visible residual disease) prior to the last chemotherapy are not eligible.
- •6. Patients may have received vaginal brachytherapy.
- •7. Patients may have received external beam radiotherapy.
- •8. Patients may have received hormonal treatment.
- •9. ECOG performance status of 0-1.
- •10. Patients must have an adequate organ function.
- •Hepatic function: total bilirubin within normal limits; ALT and AST = 2.5 x ULN in pts without liver metastasis. For Pts with liver metastasis: total bilirubin within normal limits, ALT or AST = 2.5 ULN
- •Coagulation parameters: International normalised ratio (INR) < 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation of institutional ULN
- •Absolute neutrophil count (ANC) = 1.0 x 109/L; platelets = 100 x 109L; haemoglobin = 9.0 g/dL. No blood or platelet transfusion during 4 weeks prior to randomization.Proteinuria < grade 2
- •Creatinine < 2,5 ULN or GFR > 30 ml/min (calculated using Cockroft & Gault equation, Jellife equation or measured by EDTA clearance )
- •Albumin level > 25 g/l. Intravenous albumin infusion is not allowed during the 2 weeks prior to inclusion.
- •11. Life expectancy of at least 12 weeks.
- •12. Patients must be fit to receive experimental therapy.
- •13. Patient’s age > 18 years.
- •14. Patients with preserved reproductive capacity must have a negative pregnancy test (ß-HCG test in urine or serum) prior to starting study treatment. Female patients of childbearing potential must agree to use 2 methods of contraception (including 1 highly effective and 1 effective method of contraception). Effective methods of contraception must be used throughout the study and for 3 months following the last dose of study treatment.
- •15. The patient should consent to the sampling of a tumor sample
排除标准
- •1. Sarcomas, small cell carcinoma with neuroendocrine differentiation, clear cell carcinomas.
- •2. Concurrent cancer therapy.
- •3.Previous treatment with XPO1 Inhibitor.
- •4.Concurrent treatment with an investigational agent or participation in another clinical trial.
- •5.Patients who received any systemic anticancer therapy including investigational agents or radiation =3 weeks (or =5 half-lives of the drug [whichever is shorter]) prior to C1D1.Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease.
- •6.Major injuries or surgery within the past 14 days prior to start of study treatment
- •and/or planned surgery during the on-treatment study period.
- •7.Previous malignant disease, except patients with other malignant disease, for which the patient has been disease-free for at least three years. Concurrent other malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •8.Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
- •9.Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safety or compliance with the protocol.
- •10.Known contraindications to Selinexor.
- •11.Known uncontrolled hypersensitivity to the investigational drugs, or to their excipients.
- •12.History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 3 months.
- •13.History of clinically significant haemorrhage in the past 3 months.
- •14.Radiotherapy to the target lesion within the past 3 months prior to baseline imaging.
- •15.Persistent grade 3 or 4 toxicity from previous chemotherapy and/or radiotherapy, except alopecia.
- •16.Active brain metastases (e.g. stable for <8 weeks, no adequate previous treatment with radiotherapy and/or surgery, symptomatic, requiring treatment with anti-convulsants. Corticoid therapy is allowed if administered as stable dose for at least one month before randomization).
- •17.Leptomeningeal disease.
- •18.Unstable cardiovascular function:
- •Symptomatic ischemia, or
- •Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree AV block or asymptomatic LAFB/RBBB will not be excluded), or
- •Congestive heart failure (CHF) of NYHA Class =3, or
- •Myocardial infarction (MI) within 3 months
- •19.Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use 2 medically acceptable methods of contraception for the duration of the trial and for 3 months afterwards.
- •20.Active or chronic hepatitis C and/or B infection.
- •21.Patients unable to swallow tablets, patients with malabsorption syndrome, or any other GI disease or GI dysfunction that could interfere with absorption of study treatment. A history of bowel obstruction requiring a nasogastric tube or intravenous infusion during the past 2 months is not allowed (except when this obstruction is caused by surgery or other non-malignant causes).
- •22.Patients unwilling to comply with the protocol.
研究者
相似试验
进行中（未招募）
1 期
A prospective randomised controlled phase III trial of gemcitabine and docetaxel compared with doxorubicin as first line treatment in previously untreated advanced unresectable or metastatic soft tissue sarcomas - GeDDiSocally advanced unresectable or metastatic soft tissue sarcoma.MedDRA version: 14.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014907-29-GBniversity College London257
进行中（未招募）
1 期
A trial comparing the pembrolizumab platinum based chemotherapy combination with pembrolizumab monotherapy in first line treatment of non small-cell lung cancer (NSCLC) patientsFirst line, stage IV non small-cell lung cancer (NSCLC) with PD L1 expression on =50 % of tumor cellsMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002626-86-FRCHRU de Brest292
已完成
不适用
A Prospective, Multi-Center Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreaticocally Advanced, Unresectable Pancreatic CancerJPRN-UMIN000028626niversity of Texas Southwestern Medical Center103
已完成
3 期
A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancercancer of the ovaries1003859410029903ovarian cancerNL-OMON35952niversitair Medisch Centrum Sint Radboud230
进行中（未招募）
1 期
Saline hypertonic in preschoolers and lung structure as measured by computed tomography.Cystic FibrosisEUCTR2015-004143-39-FRErasmus MC120