SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01513356

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Evaluation of PI3K/AKT/mTOR Signaling Pathway Using BKM120 in Early Breast Cancer

BKM120 is a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor, currently under investigation in a first-in-man study in patients with advanced solid tumors (wild type and PIK3CA-mutated). Consistent, dose-dependent pharmacodynamic activity has been demonstrated and clear signs of anti-tumor activity have been seen with BKM120.

NCT01513356 Breast Cancer
MeSH: Breast Neoplasms
HPO: Breast carcinoma Neoplasm of the breast

1 Interventions

Name: BKM120

Description: BKM120 will be administered on a continuous once daily dosing schedule at a dose of 100 mg (p.o.)until progression of disease or unacceptable toxicity or a maximum of 4 weeks.

Type: Drug

CBKM120


Primary Outcomes

Description: Biomarkers assessments must be performed at baseline and at the end of study treatment. The following biomarkers will be assessed: PI3K, KRAS, pAkt and -RPS6p

Measure: - To determine the grade of inhibition of PI3K/mTOR pathways, in pre-surgery setting with BKM120

Time: 28 days

Secondary Outcomes

Measure: Number, grade and relationship of adverse events with BKM120

Time: 28 days

Measure: Potential predictive biomarkers (PI3K mutation, KRAS, pAkt and RPS6p) for a pathologic complete response relating to BKM120

Time: 28 days

Single Group Assignment


There is one SNP

SNPs


1 P13K

- Patients must meet the following laboratory criteria within 7 days prior to start the study treatment: - Hematology - Neutrophil count of > 1200/mm3 - Platelet count of > 100,000/ mm3 - Hemoglobin > 90g/L - Biochemistry - AST/SGOT and ALT/SGPT < 2.5 x upper limit of normal (ULN) or < 5.0 x ULN if the transaminase elevation is due to liver metastases - Total bilirubin < 1.5 x ULN [Patients with Gilbert Syndrome must have total bilirubin < 3 ULN] - Cholesterol < ULN - 7.75 mmol/L and Triglycerides < ULN - 2.5 x ULN (with lipid-lowering drugs permitted) - Serum creatinine < 1.5 x ULN or 24-hour creatinine clearance > 60 mL/min - Serum albumin > LLN or > 30 g/L - Fasting plasma glucose ≤ 140 mg/dL (7.8 mmol/L) Exclusion Criteria: - Patients who have received prior treatment with a P13K inhibitor - Patients with a known hypersensitivity to BKM120 or to its excipients - Patients with a history of photosensitivity reactions to other drugs - Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patient's mood assessment questionnaire: - Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others) - ≥ CTCAE grade 3 anxiety The psychiatric judgment overrules the mood assessment questionnaire result/investigators judgment. --- P13K ---



HPO Nodes


HPO:
Breast carcinoma
Genes 95
TP53 PPM1D CTNNB1 TP53 COL14A1 AKT1 AKT1 OPCML MDM2 BRCA1 SLC22A18 POLE BRCA2 BRCA1 SDHC NTHL1 PTEN XRCC3 MSH6 IDH1 RAD51C RAD51C CASP8 RB1CC1 PIK3CA PALLD KRAS PIK3CA CHEK2 BRIP1 MRE11 NTHL1 ATM TP53 RAD51D STK11 PRKN ESR1 PIK3CA KLLN MSH2 SDHD KRAS SEC23B HMMR PTEN POLD1 PIK3CA IDH2 BRCA1 PALB2 BRIP1 TP53 RAD51 RNF43 BARD1 BARD1 AAGAB AKT1 SMAD4 RAD50 STK11 CHEK2 RAD54L NBN CDKN2A SEC23B CDH1 WRN NQO2 PALB2 ATR PALB2 TWIST1 SDHB MSH2 BRCA2 BRCA1 RAD51 CHEK2 MLH1 BRCA1 FGFR2 TP53 PHB BRCA2 CDH1 PTEN BRCA2 CHEK2 CDKN2A APC MLH1 AKT1 APC
Neoplasm of the breast
Genes 123
PPM1D CTNNB1 PTEN MGMT AKT1 BRCA1 SLC22A18 BRCA1 SDHC NTHL1 XRCC3 APC IDH1 LMNA RAD51C CDKN2B PIK3CA PALLD CHEK2 NTHL1 ATM RAD51D ESR1 GNAS APC PIK3CA RASGRP1 SDHD PRKCD KRAS BAP1 IDH2 PALB2 FAS RAD51 RNF43 PRLR AKT1 CHEK2 CDKN2A CDH1 CDK4 RELA BRCA2 BRCA1 TERF2IP CHEK2 MLH1 BRCA1 PRKAR1A POT1 BRCA2 CDH1 TERT APC MLH1 AKT1 TP53 CASP10 TP53 COL14A1 AKT1 OPCML MDM2 POLE BRCA2 PTEN MSH6 RAD51C CASP8 RB1CC1 KRAS ACD PIK3CA BRIP1 MRE11 TP53 STK11 PRKN KLLN MSH2 SEC23B HMMR PTEN POLD1 PIK3CA BRCA1 MITF FAS BRIP1 TP53 BARD1 BARD1 AAGAB SMAD4 RAD50 STK11 RAD54L NBN C11ORF95 SEC23B WRN PTEN NQO2 PTEN PALB2 ATR PALB2 CDKN2A TWIST1 SDHB MSH2 MC1R FASLG RAD51 FGFR2 TP53 PHB PTEN BRCA2 CHEK2 CDKN2A APC