Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma (NCT02293005) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
United States28 participantsStarted 2015-05-20
Plain-language summary
Objectives:
Objectives
The primary objective of this study is to:
To assess 4-month disease control rate (DCR) in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with alisertib
The secondary objectives of this study are to:
To assess the response rate (confirmed and unconfirmed complete + partial responses) To assess the progression-free survival. To assess overall survival. To evaluate the side effects and toxicities associated with this treatment regimen.
To collect archival tissue, blood, pleural effusion fluid and plasma for correlative studies.
Exploratory Objectives:
To collect archival or new tissue, blood and pleural effusion fluid for correlative studies. Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc gene amplification.
Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
✓. Female subject is either: post-menopausal for at least one year before the screening visit, or surgically sterilized, or willing 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 and at least 1 month after the last dose of alisertib.
✓. Male subject, even if surgically sterilized (ie, status postvasectomy), agrees to use an acceptable barrier method for contraception (condom with a spermicidal agent), or completely abstain from heterosexual intercourse during the entire study treatment period through 4 months after the last dose of alisertib.
✓. Total bilirubin \</= 1.5 x upper limit of normal (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
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable)
Exclusion criteria
✕. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
✕. Prior allogeneic bone marrow or organ transplantation
✕. 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 with significant removal of the small intestine, 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. Patients who use CPAP or BIPAP at night and have controlled sleep apnea syndrome are allowed.
✕. Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed.
✕. 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, 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 Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.