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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03770000
Other study ID # RP6530+Romidepsin-1805
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 12, 2019
Est. completion date May 14, 2021

Study information

Verified date October 2022
Source Rhizen Pharmaceuticals SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 14, 2021
Est. primary completion date May 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Pathologically confirmed T-cell lymphomas at the enrolling institution. 2. Disease status as defined as relapsed or progressed patients who have received at least one systemic therapy. 3. The patients should have received NOT more than three prior systemic combination chemotherapies 4. PTCL patients must have measurable disease defined as at least one bidimensional measurable lesion with minimum measurement of > 1.5 cm in the longest diameter. 5. Must have ECOG performance status = 2 6. Adequate bone marrow, liver and renal function in line with below mentioned laboratory requirements. 1. Hemoglobin =8.0 g/dL 2. Absolute neutrophil count (ANC) =1,000/µL 3. Platelet count =75,000/µL 4. Total bilirubin =1.5 times the ULN (or =3 x ULN, if patient has Gilbert syndrome) 5. AST (SGOT) and ALT (SGPT) = 3 x ULN; = 5 ULN in case of liver involvement 6. Calculated creatinine clearance (CrCl) > 50 ml/min by Cockcroft-Gault formula 7. Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential. 8. Provide written informed consent prior to any study-specific screening procedures. 9. Willingness and capability to comply with the requirements of the study Exclusion Criteria: 1. Patient receiving anticancer therapy including any investigational therapy =3 weeks or 5 half-lives (whichever is shorter) prior to C1D1. 2. Patient who discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to drug toxicity. 3. PTCL patients with Allo-SCT on active GVHD or immunosuppression therapy within 3 months prior to C1D1. CTCL patients with the history of Allo-SCT will be excluded. 4. Patient with medical conditions requiring the use of systemic immunosuppressive medications (> 20 mg/day of prednisone or equivalent). 5. Severe bacterial, viral or mycotic infection requiring systemic treatment. 6. Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV) infection. 7. Known seropositive requiring anti-viral therapy for hepatitis B virus (HBV) infection OR evidence of active hepatitis B infection as defined by detectable viral load if the antibody tests are positive.. 8. Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection OR patients with positive hepatitis C virus Ab. 9. Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti- EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection. 10. Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy. 11. Uncontrolled or significant cardiovascular disease including, but not limited to: - Congenital long QT syndrome. - QTcF interval > 450 msec - Myocardial infarction or stroke/TIA within the past 6 months - Uncontrolled angina within the past 3 months - Significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block (AV) block type II, 3rd degree AV block. - History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes), - History of other clinically significant heart disease (ie, cardiomyopathy, congestive heart failure with NYHA functional classification III-IV, pericarditis, significant pericardial effusion) - Requirement for daily supplemental oxygen therapy.

Study Design


Intervention

Drug:
Tenalisib
Tenalisib, BID orally daily
Romidepsin
Romidepsin IV

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States University of Colorado Cancer Center Aurora Colorado
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Rush University Cancer Center Chicago Illinois
United States Cleveland Clinic Taussig Cancer Institute Cleveland Ohio
United States The University of Kansas Cancer Center Fairway Kansas
United States John Theurer Cancer Center, Hackensack University Medical Center Hackensack New Jersey
United States The University of Texas MD Anderson Cancer Center, Houston Texas
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Norton Cancer Institute, St Matthews Campus Louisville Kentucky
United States University of Miami-Sylvester Comprehensive Cancer Center Miami Florida
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States Oregon Health & Science University Portland Oregon
United States University of California, Hellen Diller Family Comprehensive Cancer Center San Francisco 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 Number of Participants With and Without Dose Limiting Toxicities (DLTs) The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. 28 days
Secondary Overall Response Rate (ORR) With Tenalisib and Romidepsin Combination Overall response (ORR) = CR + PR) was assessed according to the Lugano classification with PTCL and according to the modified Severity Weighted Assessment Tool (mSWAT)/Global assessment in patients with CTCL. 12 weeks
Secondary Duration of Response (DoR) With Tenalisib and Romidepsin Combination The time period from the response achieved in patient until the disease progression 28 weeks
Secondary Maximum Observed Plasma Concentration (Cmax) Assessment of Cmax in subjects treated with Tenalisib and Romidepsin combination. Blood samples for measurement of RP6530 plasma concentrations were collected pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 11 hours after dosing on Day 8 of the first cycle. Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data. 8 days
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