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

Active:	No
Cancer Type:		NCT ID:	NCT03397706
Trial Phases:	Phase I Phase II	Protocol IDs:	VT3996-201 (primary) NCI-2018-00416
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Viracta Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03397706

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 Epstein-Barr Virus Associated Lymphoma (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 Tablet
Pharmacokinetic (PK) cohort to investigate the PK parameters of the tablet formulation.

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