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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02567656
Other study ID # RP6530-1401
Secondary ID 124584
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


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
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