NCT02567656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2019

Enrollment Period

2.5 years

First QC Date

September 3, 2015

Results QC Date

November 6, 2019

Last Update Submit

December 23, 2019

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, Cutaneous

Keywords

CTCLPTCLRP6530

Outcome Measures

Primary Outcomes (1)

  • Safety of RP6530

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

    28 days

Secondary Outcomes (3)

  • Overall Response Rate (ORR) With RP6530

    8 months

  • Duration of Response (DOR) With RP6530

    24 months

  • Peak Plasma Concentration (Cmax)

    Day 1 of Cycle 1

Study Arms (1)

Single arm

EXPERIMENTAL

RP6530 administered orally twice a day.

Drug: RP6530

Interventions

RP6530DRUG

Tablet starting at 200 mg

Also known as: PI3K inhibitor
Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

Location

Chao Family Comprehensive Cancer Center University of California Irvine

Orange, California, 92868, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0944, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5028, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, Cutaneous

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Prajak Barde MD
Organization
Rhizen Pharmaceuticals S.A.
pjb@rhizen.com
+41 32 580 0113

Study Officials

  • Auris Huen, MD

    MD Anderson Cancer Center, Houston, Tx.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2015

First Posted

October 5, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2018

Study Completion

December 10, 2018

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(8)