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

• Status: Completed
• Trial end date: 2018-12-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhizen Pharmaceuticals SA
• Treatments: Tenalisib

Criteria

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.