Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib
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|ClinicalTrials.gov Identifier: NCT01487265|
Recruitment Status : Completed
First Posted : December 7, 2011
Results First Posted : December 13, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: BKM120 and Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||May 31, 2016|
|Actual Study Completion Date :||December 11, 2017|
Experimental: BKM120 and Erlotinib
Cycle 1: BKM120 80 mg PO daily; Erlotinib 100mg PO daily
Cycles 2 and beyond: BKM120 100 mg PO daily; Erlotinib 100mg PO daily
Drug: BKM120 and Erlotinib
BKM120 and Erlotinib will be given once daily. Erlotinib 100 mg PO will be administered. During Cycle 1-Week 1 all patients will receive 80 mg PO daily BKM120. After the first week of Cycle 1, the dose of BKM120 will escalate to 100 mg PO daily and treatment will continue as long as there are no unexpected or prohibitive toxicities, or disease progression.
Other Name: Buparlisib (BKM 120) and Tarceva (erlotinib)
- Progression Free Survival at 3 Months [ Time Frame: 3 months ]Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.
- Overall Survival [ Time Frame: every 3 months after study treatment, projected 24 months ]Defined as the time from first treatment until death from any cause.
- Duration of Response [ Time Frame: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months ]Defined as the time from complete or partial response (CR or PR) until objective tumor progression. Tumor measurements will be obtained using CT scans of chest, abdomen and pelvis and assessed per RECIST v 1.1. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
- Objective Response Rate [ Time Frame: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months ]Defined as the percentage of complete and partial responses (CR + PR) among all patients. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
- Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety. [ Time Frame: Every 2 weeks for 8 weeks, then every 8 weeks thereafter, estimated 24 months ]Adverse events will be graded using CTCAE v4.3. and will be collected until 30 days after the discontinuation of study treatment for each participant. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487265
|United States, Florida|
|Florida Cancer Specialists South|
|Fort Myers, Florida, United States, 33916|
|Florida Hospital Cancer Institute|
|Orlando, Florida, United States, 32804|
|Florida Cancer Specialists North|
|Saint Petersburg, Florida, United States, 33705|
|Florida Cancer Specialists East|
|West Palm Beach, Florida, United States, 33401|
|United States, Ohio|
|Oncology Hematology Care, Inc.|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|United States, Texas|
|Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||David R Spigel, MD||SCRI Development Innovations, LLC|