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Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies

Status
Completed
Cancer Type
Hematopoietic Malignancies
Lymphoma
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03397706
Protocol IDs
VT3996-201 (primary)
NCI-2018-00416
Study Sponsor
Viracta Therapeutics, Inc.

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.

Objectives

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.

Eligibility

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