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

NCT ID: NCT02567656

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-12-10

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.

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

RP6530 administered orally twice a day.

Group Type: EXPERIMENTAL

RP6530

Intervention Type: DRUG

Tablet starting at 200 mg

Interventions

RP6530

Tablet starting at 200 mg

Intervention Type: DRUG

Other Intervention Names

PI3K inhibitor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhizen Pharmaceuticals SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Auris Huen, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston, Tx.

Locations

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

Emory University School of Medicine

Atlanta, Georgia, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

124584

Identifier Type: OTHER

Identifier Source: secondary_id

RP6530-1401

Identifier Type: -

Identifier Source: org_study_id