The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.
The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Escalating doses starting at 25 mg BID
Rhizen Trial Site
Paris, France
Rhizen Trial Site 1
Milan, Italy
Rhizen Trial Site 2
Milan, Italy
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
* To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. * PK parameter AUC, Cmax, tmax, t1/2 will be determined.
Time frame: 28 days
Clinical response following administration of RP6530
Overall response rate (ORR) and duration of response (DOR).
Time frame: 8 weeks
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