This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL. Approximately 65 patients are to be enrolled. The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective. The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Pierre-Bénite, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Freiburg im Breisgau, Germany
Novartis Investigative Site
Mainz, Germany
Number of participants with adverse events (AEs)
Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes
Time frame: 24 months
Incidence rate of dose limiting toxicities (DLTs)
Time frame: 24 months
Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15
Time frame: Cycle = 28 days
Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib)
Time frame: 24 Months
AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
Best Overall Response (BOR)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Complete Response (CR)
Time frame: 24 months
Partial Response (PR)
Time frame: 24 months
Stable disease (SD)
Time frame: 24 months
Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.