There are 2 clinical trials
RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to see how well it works in treating young patients with relapsed or refractory solid tumors
To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile ---
Description: DLT will be defined as possibly, probably or definitely attributable to MLN8237. The DLT observation period for the purposes of dose-escalation will be the first cycle of therapy
Measure: Adverse events as assessed by (CTCAE) version 4.0 Time: Every 21 days (each cycle) of protocol therapy for up to 35 cycles [up to 105 weeks]Description: single-dose AUC, trough estimation, t½ of accumulation
Measure: PK Profile: MLN8237 concentrations in plasma samples Time: 30 min after the first dose, and at 1,2, 3, 4, 6-8, 24 hours, Day 4 and 7 in Cycle 1This phase II trial is studying the side effects of and how well alisertib works in treating young patients with relapsed or refractory solid tumors or leukemia. Alisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
To explore the relationship between polymorphic variations in the UDP-glucuronosyltransferase gene UGT1A1 and exposure to MLN8237, and to assess 2 common polymorphic variants in the aurora A kinase gene, Phe31Ile and Val57Ile. --- Phe31Ile ---
Description: For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.
Measure: Number of Participants With Overall Response Time: From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.Description: The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.
Measure: Number of Patients Cycles With Grade 3 or Higher Adverse Event Time: Up to 24 monthsDescription: Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib Prior to the First Day of Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration Time: day 1 of protocol therapyDescription: Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose Time: day 4 of protocol therapyDescription: Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.
Measure: Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose. Time: day 7 of protocol therapy