Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Elizabeth Brem, MD

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Epstein-Barr Virus Associated Lymphoma, Lymphoproliferative Disorders, EBV+ post-transplant lymphoproliferative malignancy, EBV-associated lymphoproliferative disorders associated with acquired immunodeficiency, Relapsed, refractory, EBV+ lymphoid malignancy, Epstein-Barr Virus Infections, Neoplasms, Valganciclovir, VRx-3996

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC Irvine Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • USC Norris Comprehensive Cancer Center in progress, not accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at UC Irvine

  • Elizabeth Brem, MD
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Viracta Therapeutics, Inc.
Links
Viracta Therapeutics, Inc.
ID
NCT03397706
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 65 study participants
Last Updated