Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Orange

Grapefruit Seed Extract

Bitter Orange

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.

BKM120

Byoung Chul Cho, M.D., Ph.D.

Byoung Chul Cho, MD

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.

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.

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

An Open Label, Single Arm, Multicenter Phase II Study of BKM120 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck Who Failed to Respond to Platinum-based Therapy

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).

Overall objective response rate (ORR) is the best response rate stipulated as complete response (CR) or partial response (PR) (target lesion and tumor response defined according to RECIST guideline version 1.1) and identified as percentage of the confirmed patients.

From C1D1 to 1 months after the last dose adminitration

Overall safety profile verified as relevance of adverse events and laboratory abnormality in the study and grades granted based on (USA National Cancer Center) Common Terminology Criteria for Adverse Events such as the type, frequency and severity (CTCAE), v4.0.

From C1D1 until confirmed disease progression or death

Quality of life assessment will be performed using FACT-HN\& questionnaire

FACT-H\&N questionnaire includes physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and head \& neck cancer subscale (HNCS).

Patients will be evaluation on baseline, day 1 of every cycle (4 weeks), and end of treatment.

From C1D1 until confirmed disease progression.

Yonsei University

Assistant professor

Amino Acids

Dacomitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

45 mg P.O. Daily (28-day treatment as one treatment cycle)

PF-00299804

Byoung Chul Cho, M.D.,Ph.D.

Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patients with HNSCC. PF-00299804 is a second-generation quinazoline-based irreversible pan-HER inhibitor. In preclinical studies, PF-00299804 has much lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations (1.2 nM versus 2,700 nM) and produces tumor growth inhibition in gefitinib-resistant xenografts. A phase II trial of PF-00299804 in patients with recurrent or metastatic HNSCC is currently ongoing and preliminary report in ASCO 2010 showed its anti-tumor activity against HNSCC. The investigators suggest a phase II trial of pan-HER inhibitor PF-00299804 in patients with recurrent or metastatic HNSCC previously treated with platinum-based chemotherapy.

PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma

Phase II Trial of PF-00299804 in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy

Tumor assessment by RECIST criteria version 1.1 will be followed every 8 weeks treatment until disease progression

from C1D1 until confirmed disease progression or death

from C1D1 to 1 months after the last dose adminitration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck	NCT01527877	Head Neck Cance... Head Neck Cance...	BKM120	20 Years - 80 Years	Yonsei University
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma	NCT01449201	Head Neck Cance... Head Neck Cance...	PF-00299804	18 Years -	Yonsei University
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma	NCT01449201	Head Neck Cance... Head Neck Cance...	PF-00299804	18 Years -	Yonsei University
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma	NCT01449201	Head Neck Cance... Head Neck Cance...	PF-00299804	18 Years -	Yonsei University

Spots Global Cancer Trial Database for head neck cancer squamous cell metastatic