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Report for Clinical Trial NCT02113878

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ib Study of BKM120 With Weekly Cisplatin and Radiotherapy in High Risk Locally Advanced Squamous Cell Cancer of the Head and Neck

This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

NCT02113878 Carcinoma, Squamous Cell of Head and Neck HPV Positive Oropharyngeal Squamous Cell Carcinoma Hypopharyngeal Cancer Early Invasive Cervical Squamous Cell Carcinoma Carcinoma of Larynx Cancer of Nasopharynx
MeSH: Carcinoma Carcinoma, Squamous Cell Neoplasms, Squamous Cell Hypopharyngeal Neoplasms Squamous Cell Carcinoma of Head and Neck Nasopharyngeal Neoplasms Nasopharyngeal Carcinoma
HPO: Carcinoma Neoplasia of the nasopharynx Squamous cell carcinoma

3 Interventions

Name: BKM120

Description: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.

Type: Drug

BKM120

Name: Cisplatin

Description: Cisplatin is a chemotherapy drug

Type: Drug

BKM120

Name: Intensity-modulated radiotherapy (IMRT)

Description: IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells

Type: Radiation

BKM120


Primary Outcomes

Description: Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin in combination with radiation therapy in patients with locally advanced squamous cell cancer of the head and neck.

Measure: Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin combination with radiation therapy

Time: 2 Years

Secondary Outcomes

Measure: Overall Response Rate

Time: 2 Years

Measure: Time to Progression

Time: 2 Years

Measure: Survival

Time: 2 years

Measure: Mood alteration from BKM120

Time: 2 Years

Measure: Activity of BKM120 as single agent in sequential biopsies

Time: 2 Years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range - Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome) - Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min - Serum amylase ≤ ULN - Serum lipase ≤ ULN - Fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L) - Signed informed consent - INR ≤ 2 Exclusion Criteria: - Distant metastatic disease - Less than or equal to 10 pack years of tobacco history - Received prior chemotherapy - Received prior radiation to the head and neck or adjacent anatomical site - Received prior treatment with a P13K inhibitor. --- P13K ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Neoplasia of the nasopharynx
Genes 3
TP53 MST1R STK11
Squamous cell carcinoma
Genes 79
COL7A1 WNT10A CDKN2A GJB6 FDPS LZTS1 GTF2H5 TERT NLRP1 ERCC5 NUTM1 ERCC2 RSPO1 LAMA3 TMC8 CTSC ING1 RECQL4 GJB2 ERCC2 TGFBR2 ERCC4 LAMC2 LAMB3 MPLKIP TARS1 ERCC3 XPC DOCK8 BLM NTHL1 TYR PSENEN WRAP53 GTF2E2 IL7 RNF6 SLC17A9 TNFRSF10B DKC1 POLH RECQL4 BLM BRD4 KRT5 TMC6 TERC ERCC2 SASH1 WNT10A MC1R CIB1 SLC45A2 MVD WRN KRT14 DDB2 RNF113A DCC FERMT1 TYR COL7A1 ERCC3 ERCC3 COL7A1 MMP1 COL7A1 GJB2 SLX4 MMP1 LMNA MVK TINF2 WWOX GJB2 OCA2 CIB1 POLH STAT1