Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck
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.
Head Neck Cancer Squamous Cell Metastatic
Head Neck Cancer Squamous Cell Recurrent
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Disease control rate at 8 weeks [ Time Frame: Eight weeks after administration of the drug ] [ Designated as safety issue: No ]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 response rate (ORR) [ Time Frame: Every 8 weeks from date of first treatment until date of last treatment up to 24 months ] [ Designated as safety issue: No ]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.
- Toxicity profile [ Time Frame: Every 4 weeks from date of first treatment until date of last treatment up to 24 months ] [ Designated as safety issue: Yes ]
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.
- Overall survival [ Time Frame: Every 8 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months ] [ Designated as safety issue: No ]From C1D1 to death
- Progression-free survival [ 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 ] [ Designated as safety issue: No ]From C1D1 until confirmed disease progression or death
- Quality of life assessment [ Time Frame: Every 4 weeks from date of first treatment until the date of death from any cause, assessed approximately up to 24 months ] [ Designated as safety issue: No ]
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 to progression (TTP) [ Time Frame: Every 8 weeks from date of first treatment until the date of first documented progression, assessed approximately up to 24 months ] [ Designated as safety issue: No ]From C1D1 until confirmed disease progression.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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.
|Contact: Byoung Chul Cho, M.D., Ph.D.||email@example.com|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Contact: Byoung Chul Cho, MD 82-2-2228-8126 firstname.lastname@example.org|
|Principal Investigator: Byoung Chul Cho, M.D., Ph.D.|
|Principal Investigator:||Byoung Chul Cho, M.D., Ph.D.||Yonsei University|