Spots Global Cancer Trial Database for Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies
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Trial Identification
Brief Title: Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies
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
Study ID: NCT03397706
Study Description
Brief 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.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, United States
University of Colorado Anschutz Cancer Pavilion, Aurora, Colorado, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
ASCLEPES Research Centers, Weeki Wachee, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Ruth M Rothstein CORE Center, Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States
The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
St. Vincent Healthcare Cancer Center, Billings, Montana, United States
John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
The Ohio State University Wexner Medical Center James Cancer Hospital, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
Centro de Hematologia e Oncologia da Bahia (CEHON), Salvador, BA, Brazil
Hospital de Cancer de Pernambuco (HCP), Recife, PE, Brazil
Hospital do Cancer Mae de Deus, Porto Alegre, Rio Grande Do Sul, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo, SP, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP), São Paulo, SP, Brazil
Hospital Santa Marcelina, São Paulo, SP, Brazil
Contact Details
Name: Jill DeFratis Robinson
Affiliation: Viracta Therapeutics
Role: STUDY_DIRECTOR
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