Back to Clinical Trials

Humanin

HN, S14G-Humanin

Quick Stats

Studies 491

Trials 100

Overview Studies Clinical Trials

Unknown PHASE2 INTERVENTIONAL NCT01527877

Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study is to evaluate disease control rate (DCR) at 8 weeks of BKM120 administered as therapy for patient with recurrent/metastatic head and neck squamous cell carcinoma.

Detailed Description

One promising approach to the treatment of cancer is inhibition or modulating the crucial signal transduction pathway of PI3K-Akt-mTOR. Several PI3K inhibitors are being tested in the clinical trials for cancer treatment but not for the head and neck cancer yet. BKM120 is a specific Pan-class I PI3K inhibitor. We suggest multicenter single arm phase II study to determine anti-tumor effects of BKM120 in patients with recurrent and/or metastatic SCCHN who failed to prior platinum-based chemotherapy regimens.

Interventions

Name: BKM120

Type: DRUG

Description: Patients will be instructed to take BKM120 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day. The patient will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. If vomiting occurs no attempt should be made to replace the dose. • BKM120 should be taken 1-hour following a light meal. Please note that patients must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction. Regular orange juice is allowed.

Primary Outcomes

Measure: Disease control rate at 8 weeks

TimeFrame: Eight weeks after administration of the drug

Description: The disease control rate (DCR) is defined as the proportion of randomized patients achieving a best overall response of PR or CR or SD, defined by RECIST criteria (version 1.1), relative to the total number of patients in the considered analysis population (ITT).

Trial Information

NCT ID

NCT01527877

Status

Unknown

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Yonsei University

Last Updated

December 15, 2025