To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Tenalisib, BID orally daily
Romidepsin IV
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Number of Participants With and Without Dose Limiting Toxicities (DLTs)
The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: 28 days
Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination
Overall response (ORR) = CR + PR) was assessed according to the Lugano classification with PTCL and according to the modified Severity Weighted Assessment Tool (mSWAT)/Global assessment in patients with CTCL.
Time frame: 12 weeks
Duration of Response (DoR) With Tenalisib and Romidepsin Combination
The time period from the response achieved in patient until the disease progression
Time frame: 28 weeks
Maximum Observed Plasma Concentration (Cmax)
Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination. Blood samples for measurement of RP6530 plasma concentrations were collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 11 hours after dosing on Day 8 of the first cycle. Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data.
Time frame: 8 days
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