Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

Rhizen Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Lymphoma, T-Cell, Cutaneous

Lymphoma, T-Cell, Peripheral

Treatments

Drug: RP6530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02567656

124584 (Other Identifier)

RP6530-1401

Details and patient eligibility

About

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.

Full description

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
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 3 weeks or limited palliative radiation <2 weeks
Patients with HBV, HCV or HIV infection
Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
Patients on immunosuppressive therapy including systemic corticosteroids.
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.