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

Phase 1

Completed

• Conditions: Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
• Interventions: Drug: RP6530

• Registration Number: NCT02567656
• Lead Sponsor: Rhizen Pharmaceuticals SA

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2018-03
• Study Completion: 2018-12-10
• Results First Submitted: 2019-11-06
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-23
• Last Update Submitted: 2019-12-23
• Results First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	RP6530	RP6530 administered orally twice a day.

Primary Outcome Measures

Name	Time	Method
Safety of RP6530	28 days	Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0

Secondary Outcome Measures

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

Trial Locations

Locations (8)

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

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States