Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma (NCT02567656) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
United States58 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.