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Report for Clinical Trial NCT02444884

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH: Neuroblastoma
HPO: Neuroblastoma

1 Interventions

Name: MLN8237

Type: Drug

Stratum A1 Stratum A2 Stratum B


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 therapy

Measure: 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

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 F31I

To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile ---


2 V57I

To assess two common polymorphic variants in the Aurora A kinase gene (Phe31Ile and Val57Ile) thought to potentially influence tumorigenesis. --- Phe31Ile --- --- Val57Ile ---



HPO Nodes


HPO:
Neuroblastoma
Genes 53
TUBB GPC4 BDNF NUTM1 PHOX2B MLH1 PMS2 RET MSH6 PRDM16 PHOX2B RERE SDHB MSH6 PHOX2B NF1 EPCAM KIF1B EDN3 TUBB TGFBR2 SEMA4A ASCL1 RET FAN1 GABRD ASCL1 RAF1 RUNX1 GDNF GDNF BRAF BMPR1A KRAS BRD4 MLH1 MSH2 PMS2 MLH3 GPC3 PTPN11 MYO1H PIK3CA PHOX2B KCNAB2 MAPRE2 RPS20 PHOX2B PMS1 EDN3 PALB2 MSH2 SKI