Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Rhizen Pharmaceuticals SA
• Treatments: Tenalisib

Criteria

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.