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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RP6530
Sponsored by
Rhizen Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell, Peripheral focused on measuring CTCL, PTCL, RP6530

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope
  • Chao Family Comprehensive Cancer Center University of California Irvine
  • University of Colorado Cancer Center
  • Emory University School of Medicine
  • University of Michigan Comprehensive Cancer Center
  • Karmanos Cancer Institute
  • University Hospitals Cleveland Medical Center
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

RP6530 administered orally twice a day.

Outcomes

Primary Outcome Measures

Safety of RP6530
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0

Secondary Outcome Measures

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).
Duration of Response (DOR) With RP6530
The time period from the response achieved in patient until the disease progression.
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of RP6530

Full Information

First Posted
September 3, 2015
Last Updated
December 23, 2019
Sponsor
Rhizen Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT02567656
Brief Title
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
Keywords
CTCL, PTCL, RP6530

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
RP6530 administered orally twice a day.
Intervention Type
Drug
Intervention Name(s)
RP6530
Other Intervention Name(s)
PI3K inhibitor
Intervention Description
Tablet starting at 200 mg
Primary Outcome Measure Information:
Title
Safety of RP6530
Description
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) With RP6530
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).
Time Frame
8 months
Title
Duration of Response (DOR) With RP6530
Description
The time period from the response achieved in patient until the disease progression.
Time Frame
24 months
Title
Peak Plasma Concentration (Cmax)
Description
Peak Plasma Concentration (Cmax) of RP6530
Time Frame
Day 1 of Cycle 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auris Huen, MD
Organizational Affiliation
MD Anderson Cancer Center, Houston, Tx.
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5028
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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