Phase 1
N=58
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
Lymphoma, T-Cell, Peripheral · Lymphoma, T-Cell, Cutaneous
Bottom Line
View on ClinicalTrials.gov: NCT02567656 ↗Enrolled (actual)
58
Serious AEs
10.3%
Results posted
Jan 2020
Primary outcome: Primary: Safety of RP6530 — 0; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RP6530 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rhizen Pharmaceuticals SA
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of RP6530 |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Overall Response Rate (ORR) With RP6530 |
1; 2; 2; 2; 4; 5 | — |
| SECONDARY Duration of Response (DOR) With RP6530 |
147; 72; 313; 99; 141; 307 | — |
| SECONDARY Peak Plasma Concentration (Cmax) |
1297.65; 2196.65; 3995.68; 2668.05 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02567656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.