The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Tablet starting at 200 mg
City of Hope
Duarte, California, United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Emory University School of Medicine
Safety of RP6530
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Time frame: 28 days
Overall Response Rate (ORR) With RP6530
ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).
Time frame: 8 months
Duration of Response (DOR) With RP6530
The time period from the response achieved in patient until the disease progression.
Time frame: 24 months
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of RP6530
Time frame: Day 1 of Cycle 1
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Atlanta, Georgia, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States