Trial | NCT03397706  Report issue

Title

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies
A Phase 1b/2 Open-Label, Dose Escalation & Expansion Study of Orally Administered VRx-3996 & Valganciclovir in Subjects With Epstein-Barr Virus-Associated Lymphoid Malignancies

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    65
A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in relapsed/refractory EBV+ lymphomas.
The purpose of this study is to determine whether VRx-3996 in combination with valganciclovir is safe, determine the side effect profile, and to determine whether this therapy may help patients with EBV-related lymphomas. The study has two phases. Goals of the first phase include determining a safe and tolerable dose that can be administered in phase 2. Goals of the second phase include further evaluating the safety and tolerability of VRx-3996 in combination with valganciclovir, evaluating how the drugs are metabolized in the body, evaluating response rates and other exploratory objectives that will help the researchers evaluate how these drugs work in the body. Participants will receive daily oral doses of the two study drugs and will have multiple study visits where they will have blood collected, physical examinations, and other medical monitoring. Following completion of the Ph2, the study will enroll additional patients into a PK cohort to investigate the PK parameters of the tablet formulation.
Study Started
Mar 29
2018
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Jul 28
2021

Drug VRx-3996

Taken orally once or twice daily

  • Other names: Nanatinostat

Drug Valganciclovir

Taken orally once or twice daily

Phase 1b Dose Escalation Experimental

VRx-3996 (cohort 1) and valganciclovir VRx-3996 (cohort 2) and valganciclovir VRx-3996 (cohort 3) and valganciclovir VRx-3996 (cohort 4) and valganciclovir VRx-3996 (cohort 5) and valganciclovir

Phase 2 Dose Expansion Experimental

VRx-3996 (RP2D: recommended phase 2 dose) and valganciclovir

PK Cohort Experimental

Assessment of VRx-3996 tablet and valganciclovir PK parameters at the RP2D

Criteria 

Key Inclusion Criteria:

Relapsed/refractory, pathologically confirmed EBV+ lymphoid malignancy or lymphoproliferative disease
Absence of available therapy with reasonable likelihood of cure or significant clinical benefit
Adequate hematologic, hepatic and renal function as defined by laboratory assessment

Key Exclusion Criteria:

Known primary CNS lymphoma
Known CNS metastases or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Refractory graft versus host disease (GvHD) not responding to treatment
Known active hepatitis B virus infection
Circulating hepatitis C virus on qPCR
Known history of HHV-6 chromosomal integration
Known history of HIV infection
No Results Posted