SNPMiner Trials (Home Page)
Report for Mutation V57I
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Phase II Study of MLN8237, a Selective Aurora A Kinase Inhibitor in Children With Recurrent/Refractory Solid Tumors and Leukemias
This 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.
NCT01154816 Hepatoblastoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Kidney Neoplasm Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Rhabdomyosarcoma Recurrent Childhood Soft Tissue Sarcoma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Neuroblastoma Recurrent Osteosarcoma Drug: Alisertib Other: Laboratory Biomarker Analysis Other: Pharmacological Study MeSH:Leukemia Sarcoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Neuroblastoma Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Rhabdomyosarcoma, Embryonal Neuroectodermal Tumors, Primitive, Peripheral Hepatoblastoma Kidney Neoplasms Neoplasms
HPO:Embryonal rhabdomyosarcoma Ependymoblastoma Ewing sarcoma Hepatoblastoma Leukemia Medulloepithelioma Neoplasm Neuroblastoma Neuroectodermal neoplasm Osteosarcoma Peripheral primitive neuroectodermal neoplasm Primitive neuroectodermal tumor Renal neoplasm Rhabdomyosarcoma Sarcoma Soft tissue sarcoma
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 --- --- Val57Ile ---
Primary Outcomes
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.Secondary Outcomes
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 therapy2 A Phase I/II Study of MLN8237, an Oral Selective Small Molecule Inhibitor of Aurora A Kinase, in Children With Relapsed/Refractory Solid Tumors
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
NCT02444884 Unspecified Childhood Solid Tumor, Excluding CNS Neuroblastoma Drug: MLN8237 MeSH:Neuroblastoma
HPO:Neuroblastoma
To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile --- --- Val57Ile ---
Primary Outcomes
Measure: Determine maximum tolerated dose and RP2D administered once daily on Days 1-7 Time: Up to 21 days (1st cycle) of protocol therapyMeasure: Determine maximum tolerated dose and RP2D administered po BID on Days 1-7 Time: Up to 21 days (1st cycle) of protocol therapy
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 1