Clinical trial · Interventional
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma
NCT02567656CI-TRIAL-00042723completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP6530 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- RP6530 administered orally twice a day.
- interventionNames
- Drug: RP6530
Primary outcomes (1)
- measure
- Safety of RP6530
- timeFrame
- 28 days
- description
- Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Secondary outcomes (3)
- measure
- Overall Response Rate (ORR) With RP6530
- timeFrame
- 8 months
- description
- ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.