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

Completed · Phase 1

Conditions studied: Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous

In brief

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.

Key facts

Study ID

NCT02567656

Run by

Rhizen Pharmaceuticals SA

People needed

58

Starts

2015-09-01

Expected to finish

2018-12-10

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• Chao Family Comprehensive Cancer Center University of California Irvine — Orange, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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