The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12
PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate \<50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.
Time frame: Week 12
Overall Survival (OS) Using Kaplan-Meier Estimates
OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Time frame: Every 8 weeks up to 24 months
Overall Response Rate (ORR) Based on Investigator Assessment
ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.
Time frame: Every 6 weeks up to 24 months
Disease Control Rate (DCR)
DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline.
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Ironwood Cancer and Research Centers SC
Chandler, Arizona, United States
Arizona Oncology Associates Tucson (Rudasill & La Cholla)
Phoenix, Arizona, United States
Mayo Clinic - Arizona Mayo Scottsdale AZ
Scottsdale, Arizona, United States
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States
Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr.
Los Angeles, California, United States
University of California at San Diego, Moores Cancer Ctr SC
San Diego, California, United States
University of Colorado Univ CO
Aurora, Colorado, United States
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
Greenwood Village, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt
Tampa, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Emory 2
Atlanta, Georgia, United States
...and 82 more locations
Time frame: Every 6 weeks up tp 24 months
Time to Response (TTR)
TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.
Time frame: Every 6 weeks up to 24 months
Duration of Response (DoR)
DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.
Time frame: Every 6 weeks up to 24 months