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Trial record 1 of 1 for:    Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T- cell Lymphoma
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Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567656
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell, Cutaneous Drug: RP6530 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Single arm
RP6530 administered orally twice a day.
Drug: RP6530
Tablet starting at 200 mg
Other Name: PI3K inhibitor




Primary Outcome Measures :
  1. Safety of RP6530 [ Time Frame: 28 days ]
    Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) With RP6530 [ Time Frame: 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).

  2. Duration of Response (DOR) With RP6530 [ Time Frame: 24 months ]
    The time period from the response achieved in patient until the disease progression.

  3. Peak Plasma Concentration (Cmax) [ Time Frame: Day 1 of Cycle 1 ]
    Peak Plasma Concentration (Cmax) of RP6530



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567656


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, United States, 92868
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0944
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-5028
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
Investigators
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Principal Investigator: Auris Huen, MD MD Anderson Cancer Center, Houston, Tx.
  Study Documents (Full-Text)

Documents provided by Rhizen Pharmaceuticals SA:
Study Protocol  [PDF] May 23, 2018
Statistical Analysis Plan  [PDF] May 23, 2018

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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT02567656    
Other Study ID Numbers: RP6530-1401
124584 ( Other Identifier: Food and Drug Administration )
First Posted: October 5, 2015    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhizen Pharmaceuticals SA:
CTCL
PTCL
RP6530
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin