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Report for Clinical Trial NCT02977780

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115

NCT02977780 Glioblastoma
MeSH: Glioblastoma
HPO: Glioblastoma multiforme

4 Interventions

Name: Temozolomide

Description: Temzolomide capsules

Type: Drug

Abemaciclib with Temozolomide Neratinib with Temozolomide Temozolomide

Name: Neratinib

Description: Neratinib tablets

Type: Drug

Neratinib with Temozolomide

Name: CC-115

Description: CC-115 capsule

Type: Drug

CC-115

Name: Abemaciclib

Description: Abemaciclib capsules

Type: Drug

Abemaciclib with Temozolomide


Primary Outcomes

Measure: Overall Survival in Experimental Arms Compared with Standard Therapy

Time: 2 years

Secondary Outcomes

Description: Safety will be assessed by quantifying the toxicities and grades experienced by subjects, including serious adverse events (SAEs). The following will also be measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations.

Measure: Incidence of Treatment-Emergent Adverse Events

Time: 2 years

Measure: Progression Free Survival Among Experimental Arms And Biomarker Groups

Time: 2 years

Measure: Overall Survival Among Experimental Arms And Biomarker Groups

Time: 2 years

Measure: Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents

Time: 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R132H

- Immunohistochemically negative for IDH1 R132H mutation. --- R132H ---



HPO Nodes


HPO:
Glioblastoma multiforme
Genes 23
FAN1 APC BMPR1A KRAS BRCA2 RPS20 MLH1 MSH2 MSH6 EPCAM PMS2 MLH1 MLH3 PMS2 PMS1 MSH6 TP53 MSH2 TGFBR2 PIK3CA SEMA4A ERBB2 IDH1