SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT00464113
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how
often it should be taken, and how well people with leukemia tolerate XL228.
Name: XL228
Description: 1-hour IV infusionType: Drug
1 2
Primary Outcomes
Measure: Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228
Time: Assessed at periodic visits
Secondary Outcomes
Measure: Evaluate plasma pharmacokinetics and estimate renal elimination of once-weekly and twice-weekly 1-hour IV infusion of XL228
Time: Assessed at periodic visits
Measure: Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity
Time: Assessed at periodic visits
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 T315I
The subject has a confirmed pathologic diagnosis as evidenced by the presence of the
BCR-Abl translocation [t(9;22)] by fluorescence in situ hybridization (FISH),
cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the
following:
1. CML
- Chronic phase (CP)
- Accelerated phase (AP)
- Blast phase (BP) OR
2. Ph+ ALL
2. The subject has one of the following:
- Known T315I Abl mutation
- Known resistance to or intolerance of imatinib and dasatinib
- At least one prior anti-leukemia therapy, including, but not limited to,
interferon, imatinib, or dasatinib
3. The subject is at least 18 years old. --- T315I ---
HPO Nodes
HPO:Chronic myelogenous leukemia
Genes 5
MPL BCR JAK2 KIT THPO hr>Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18 hr>Lymphoid leukemia
hr>Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS hr>