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

Study Overview
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Brief Summary
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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.

Detailed Description
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Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.

Official Title
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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

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

Intervention / Treatment
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* Drug: RP6530


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>RP6530 administered orally twice a day. | Drug: RP6530<br>* Tablet starting at 200 mg<br>* Other names: PI3K inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of RP6530 | Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) With RP6530 | 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). | 8 months | 
| Duration of Response (DOR) With RP6530 | The time period from the response achieved in patient until the disease progression. | 24 months | 
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) of RP6530 | Day 1 of Cycle 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTCL, PTCL, RP6530