A Phase 2 interventional study of BKM120 in Head Neck Cancer Squamous Cell Metastatic and Head Neck Cancer Squamous Cell Recurrent, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-08.
Sponsored by Yonsei University · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 53 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Progressive disease defined as follows
Adequate organ function
Exclusion Criteria:
Severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Drug: BKM120
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.
Also known as: NVP-BKM120, BKM-120
Disease control rate at 8 weeks
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).
Time frame: Eight weeks after administration of the drug
Overall response rate (ORR)
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.
Time frame: Every 8 weeks from date of first treatment until date of last treatment up to 24 months
Toxicity profile
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.
Time frame: Every 4 weeks from date of first treatment until date of last treatment up to 24 months
Overall survival
From C1D1 to death
Time frame: Every 8 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months
Progression-free survival
From C1D1 until confirmed disease progression or death
Time frame: Every 8 weeks from date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 24 months
Quality of life assessment
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.
Time frame: Every 4 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months
Time to progression (TTP)
From C1D1 until confirmed disease progression.
Time frame: Every 8 weeks from date of first treatment until the date of first documented progression, assessed approximately up to 24 months
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Yonsei University