This is a multi-center, open-label, non-randomized, phase I study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
13
University of California at Los Angeles UCLA SC
Los Angeles, California, United States
Horizon Oncology Center SC
Lafayette, Indiana, United States
Medical University of South Carolina SC
Charleston, South Carolina, United States
South Texas Accelerated Research Therapeutics SC
San Antonio, Texas, United States
Incidence of dose-limiting toxicities (DLTs)
Dose Escalation Phase: Frequency of DLTs at each dose level associated with administration of LEE011, buparlisib, and letrozole in a 28 day cycle
Time frame: 28 days
Safety and tolerability of the combination of LEE011, buparlisib, and letrozole
Dose Expansion Phase: Incidence of AEs, SAEs (overal and severity), laboratory abnormalities, ECG, vital, dose interteruptions, dose reductions, and dose intensity as a measure of safety and tolerability.
Time frame: approximately 25 months
Safety and tolerabiity of the combination of LEE011, buparlisib, and letrozole
Dose Escalation Phase: Incidence of AEs, SAEs (overall and severity), laboratory abnormalities, ECG, vital, dose interterruptions, dose reductions, and dose intensity as a measure of safety and tolerability.
Time frame: approximately 25 months
Pharmacokinetic paramters such as AUClast and Cmax of LEE011, buparlisib, and letrozole in order to characterize the PK profiles
Dose Escalation Phase: When given in combination as well any other clinically significant metabolites that may be identified
Time frame: approximately 25 months
Pharmacokinetic paramters such as AUClast and Cmax of LEE011, buparlisib, and letrozole in order to characterize the PK profiles
Dose Expansion Phase: When given in combination as well as any other clinically significant metabolites that may be identified
Time frame: approximately 25 months
Disease control rate
Dose Expansion Phase: Proportion of patients with the best overall response of CR (complete response), PR (partial response), or SD (stable disease)
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University of Utah / Huntsman Cancer Institute SC-3
Salt Lake City, Utah, United States
Novartis Investigative Site
Madrid, Spain
Time frame: approximately 25 months
PFS (progression free survival)
Dose Expansion Phase: Time from date of start of treatment to date of first documented progression or death due to any cause.
Time frame: approximately 25 months