Lymphoma, B-Cell, T-Cell Lymphoma
Conditions
Keywords
CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
Brief summary
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.
Detailed description
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).
Interventions
DRUGRP6530
Escalating doses starting at 25 mg BID
Sponsors
Rhizen Pharmaceuticals SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Refractory to or relapsed after at least 1 prior treatment line. * ECOG performance status ≤2 * Patients must be ≥18 years of age * Able to give a written informed consent.
Exclusion criteria
* Any cancer therapy in the last 4 weeks or limited palliative radiation \<2 weeks * Patients with HBV, HCV or HIV infection * Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months. * Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib). * Patients on immunosuppressive therapy including systemic corticosteroids. * Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.). * Patients with known history of liver disorders. * Patients with uncontrolled Diabetes Type I or Type II * Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. * Women who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530 | 28 days | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response following administration of RP6530 | 8 weeks | Overall response rate (ORR) and duration of response (DOR). |
Countries
France, Italy
Outcome results
None listed