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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02154776
Other study ID # CLEE011A2112C
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 27, 2014
Est. completion date October 26, 2016

Study information

Verified date July 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, open-label, non-randomized, phase I study


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date October 26, 2016
Est. primary completion date October 26, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease. 2. Patient is postmenopausal. 3. Patient may have received = 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase. 4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory. 5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. 6. Patient must have either: - Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion Exclusion Criteria: 1. Patient who received any CDK4/6 or PI3K inhibitor. 2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: - History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry - History of documented congestive heart failure (New York Heart Association functional classification III-IV) - Documented cardiomyopathy - Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) - History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months. - On screening, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec. Systolic blood pressure >160 or <90 mmHg 3. Patient is currently receiving any of the following medications: - That are known strong inducers or inhibitors of CYP3A4. - That have a known risk to prolong the QT interval or induce Torsades de Pointes. - That have a narrow therapeutic window and are predominantly metabolized through CYP3A4. 4. Certain scores on an anxiety and depression mood questionnaires

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LEE011
3 weeks on and 1 week off
Buparlisib
daily
Letrozole
2.5 mg daily;

Locations

Country Name City State
Spain Novartis Investigative Site Madrid
United States Medical University of South Carolina SC Charleston South Carolina
United States Horizon Oncology Center SC Lafayette Indiana
United States University of California at Los Angeles UCLA SC Los Angeles California
United States University of Utah / Huntsman Cancer Institute SC-3 Salt Lake City Utah
United States South Texas Accelerated Research Therapeutics SC San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 28 days
Primary 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. approximately 25 months
Secondary 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. approximately 25 months
Secondary 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 approximately 25 months
Secondary 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 approximately 25 months
Secondary 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) approximately 25 months
Secondary 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. approximately 25 months
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