Study of BKM120 in Advanced Squamous Cell Carcinoma of Head and Neck
|ClinicalTrials.gov Identifier: NCT01527877|
Recruitment Status : Unknown
Verified October 2012 by Byoung Chul Cho, Yonsei University.
Recruitment status was: Recruiting
First Posted : February 7, 2012
Last Update Posted : October 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Head Neck Cancer Squamous Cell Metastatic Head Neck Cancer Squamous Cell Recurrent||Drug: BKM120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||August 2014|
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.
- Disease control rate at 8 weeks [ Time Frame: Eight weeks after administration of the drug ]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 ]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 ]
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 ]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 ]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 ]
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 ]From C1D1 until confirmed disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527877
|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|