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

Active:	No
Cancer Type:	Hematopoietic Malignancies Lymphoma Unknown Primary	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 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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.