EUCTR2017-004761-28-ES进行中（未招募）1 期
A multicenter, phase Ib/II trial of selinexor in combination with imatinib in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GISTs)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
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
入选标准
- •1.Age =18 years at the time of study entry.
- •2.Histologically confirmed metastatic and/or unresectable GIST. Patients must demonstrate prior failure to at least imatinib. Any number of previous therapies for GIST is allowed.
- •3.Failure of imatinib is defined as disease progression after = 6 months of treatment with imatinib for advanced/metastatic disease. Exception to this rule is GIST patients with documented KIT or PDGFRA mutations.
- •4.Measurable disease per modified RECIST 1.1.
- •5.ECOG performance status 0 to 2.
- •6.Adequate hematopoietic function (within 7 days prior to enrollment):
- •a. Hemoglobin = 9.0 g/dL (90 g/L).
- •b. Absolute neutrophil count = 1000/mm3.
- •c. Platelets = 100,000 /mm3.
- •Patients must have at least a 2-week interval from the last red blood cell (RBC) transfusion and/or growth factor support prior to the Screening hemoglobin and neutrophil assessment. However, patients may receive RBC, growth factor support, and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
- •7. Adequate organ function (within 7 days prior to enrollment):
- •a. Alanine aminotransferanse (ALT) and aspartate aminotransferanse (AST)
- •=2.5 x upper limit of normal (ULN), or = 5.0 x ULN if liver metastases are
- •b. Alkaline phosphatase (ALP) limit < 2.5 x ULN or = 5.0 x ULN if liver
- •metastases are present.
- •c. Total serum bilirubin = 2 x ULN. Patients with Gilbert’s syndrome must have a total bilirubin of < 3 × ULN.
- •d. Adequate renal function: estimated creatinine clearance of = 30 mL/min, calculated using the formula of Cockroft and Gault
- •8.Patients must be able to swallow oral medication and no malabsorption condition.
- •9.Willingness to use effective means of birth control throughout the duration of clinical study and for at least 3 months after completion of study drug.
- •10.Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of study drug administration.
- •11.Ability to understand and the willingness to sign a written informed consent document.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1.Intolerance to first-line treatment imatinib 400mg daily.
- •2.Use of any approved tyrosine kinase inhibitors or investigational agents within 1 week or 5 half-lives of the agent, whichever is shorter, prior to receiving study drugs.
- •3.Participants who have had radiotherapy within 4 weeks prior to study entry.
- •4.Major surgery or significant traumatic injury within 4 weeks prior to study entry.
- •5.Presence of symptomatic or uncontrolled brain or central nervous system metastases.
- •6.Known or suspected allergy or hypersensitivity to the selinexor, imatinib or any of its components.
- •7.Patient has a history of another primary malignancy that has been diagnosed or required therapy within 1 year prior to the first dose of study drug (The following are exempt from the 1-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.)
- •8.Unstable cardiovascular function: • Symptomatic ischemia, or • Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) will not be excluded), or • Congestive heart failure (CHF) NYHA Class = 3, or • Myocardial infarction (MI) within 3 months. • Left ventricular ejection fraction < 40 %. • Hypertension > 140 mm Hg systolic or > 90 mm Hg diastolic with or without antihypertensive therapy.
- •9.Ongoing infection > Grade 2.
- •10.Patients with any seizure disorder requiring medication.
- •11.HIV-positive individuals on combination antiretroviral.
- •12.Patients with active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- •13.Serious psychiatric or medical conditions that could interfere with treatment.
- •14.Pregnant or lactating females.
- •15.Strong CYP3A4 inhibitors (e.g. clarithromycin, indinavir , itraconazole, ketoconazole , nefazodone , nelfinavir , posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s Wort) within 28 days or 5 drug half-lives (if drug half-life in patients is known), whichever is longer, before start of study treatment.
研究者
相似试验
进行中（未招募）
1 期
Clinical trial of selinexor plus gemcitabine in selected advanced soft-tissue sarcomasCTIS2024-514827-40-00Asociacion Europea Y Latinoamericana SELNET Para La Investigacion En Sarcomas88
招募中
1 期
Pilot phase II study of Selinexor in combination with Ifosfamide, Etoposide and Dexamethasone (SIDE) in patients with relapsed or refractory Peripheral T-cell LymphomasRelapsed or Refractory Peripheral T-cell LymphomasMedDRA version: 21.0Level: PTClassification code: 10001416Term: Adult T-cell lymphoma/leukaemia recurrent Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001417Term: Adult T-cell lymphoma/leukaemia refractory Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10001413Term: Adult T-cell lymphoma/leukaemia Class: 100000004864CTIS2024-513295-18-00Fondazione IRCCS Istituto Nazionale Dei Tumori30
进行中（未招募）
1 期
Selinexor, cyclophosphamide and prednisolone compared to cyclophosphamide and prednisolone in patients with multiple myelomaMultiple myelomaEUCTR2017-001736-19-GBniversity of Leeds60
招募中
2 期
Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)Sarcoma,Soft TissueNCT06114004Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas88
进行中（未招募）
1 期
Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (SeliGIST)Maximum Tolerated DoseMetastatic Adult Soft Tissue SarcomaDrug ToxicityDrug UseGISTNCT04138381Grupo Espanol de Investigacion en Sarcomas30