A Phase 2 study of the Aurora kinase A inhibitor Alisertib (MLN8237) in patients with relapsed or refractory transitional-cell carcinoma of the bladder and urothelial tract - Alisertib in relapsed or refractory urothelial cancer

Fondazione IRCCS Istituto Nazionale dei tumori0 个研究点目标入组 130 人开始时间: 2014年3月21日最近更新: 2018年3月12日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Fondazione IRCCS Istituto Nazionale dei tumori
入组人数: 130

研究概览入排标准研究者记录与标识符相似试验

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

•Each patient must meet all of the following inclusion criteria to be enrolled in the study:
•Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
•Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium. Presence of divergent histologies (ex. squamous-cell histology) may be acceptable provided that there is prevalence (> 50%) of urothelial component.
•Locally advanced or metastatic disease.
•Age ? 18.
•Measurable disease criteria, defined as = 1 unidimensionally measurable lesion = 2 cm by conventional techniques or = 1 cm by spiral CT scan.
•SINGLE ARM PHASE: Failure of one or two platinum-based (either cisplatin or carboplatin) conventional chemotherapy regimen for metastatic disease (second and third-line setting).
•RANDOMIZED PHASE: Failure of no more than 1 platinum-based (either cisplatin or carboplatin) conventional chemotherapy regimen for metastatic disease (pure second-line setting).
•Neoadjuvant/adjuvant therapy considered if relapse occurred within 6 months of the last cycle of chemotherapy.
•Female subject is either:
•opost-menopausal for at least one year before the screening visit, or
•o surgically sterilized, or
•owilling to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
•Male subject, even if surgically sterilized (ie, status postvasectomy), agrees to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of alisertib.
•Absolute neutrophil count (ANC) > 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published ASCO guidelines.
•Total bilirubin = 1.5 x upper limit of nomal (ULN), SGOT (AST) and SGPT (ALT)< 2.5 x ULN. AST and/or ALT may be up to 5X ULN if with known liver mets
•Adequate renal function as defined by: Calculated creatinine clearance must be = 30 mL/minute(see Cockcroft-Gault formula in Section 9.5)
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (refer to Section 9.4) & life expectancy of at least 12 weeks.
•Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study.
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

排除标准

•Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
•Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
•Known GI disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib. Examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
•Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen.
•Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed as described in Section 3.4.
•Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
•Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Section 9.3), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
•Female subject who is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
•Patient has received other investigational drugs with 14 days before enrollment
•Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
•Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study.
•Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
•Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of alisertib and during the study.
•Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion. For guidance in defining active infection for hepatitis B, please refer to the WHO guidelines. (World Health Organization, Global Alert and Response (GAR), Hepatitis B. who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html)
•Prior administration of an Aurora A kinase-targeted agent, incl

研究者

发起方

Fondazione IRCCS Istituto Nazionale dei tumori

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