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

Lymphoma, T-Cell, Cutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567656
• Other study ID #: RP6530-1401
• Secondary ID: 124584
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: December 10, 2018

Study information

• Verified date: December 2019
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 10, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral

Intervention

Drug:
• RP6530
Tablet starting at 200 mg

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	Chao Family Comprehensive Cancer Center University of California Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of RP6530	Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0	28 days
Secondary	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
Secondary	Duration of Response (DOR) With RP6530	The time period from the response achieved in patient until the disease progression.	24 months
Secondary	Peak Plasma Concentration (Cmax)	Peak Plasma Concentration (Cmax) of RP6530	Day 1 of Cycle 1