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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
Group Labels: 1


Name: Cisplatin

Description: Cisplatin is a chemotherapy drug
Type: Drug
Group Labels: 1


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
Group Labels: 1


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

Allocation: N/A

Single Group Assignment

There is one SNP


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