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

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ClinicalTrials.gov Identifier: NCT03397706
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Viracta Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epstein-Barr Virus Associated Lymphoma Lymphoproliferative Disorders Drug: VRx-3996 Drug: Valganciclovir Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Phase 1: dose escalation phase (3+3 design with definitions of dose limiting toxicity) to define a recommended phase 2 dose

Phase 2: dose expansion
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1b Dose Escalation

VRx-3996 (cohort 1) and valganciclovir

VRx-3996 (cohort 2) and valganciclovir

VRx-3996 (cohort 3) and valganciclovir

VRx-3996 (cohort 4) and valganciclovir

VRx-3996 (cohort 5) and valganciclovir

 Drug: VRx-3996
capsules taken orally once or twice daily

Drug: Valganciclovir
tablets taken orally once or twice daily
Experimental: Phase 2 Dose Expansion
VRx-3996 (RP2D: recommended phase 2 dose) and valganciclovir
 Drug: VRx-3996
capsules taken orally once or twice daily

Drug: Valganciclovir
tablets taken orally once or twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events and changes in clinical safety laboratory values in Dose Escalation and Cohort Expansion [ Time Frame: Approximately 2 years ]
    Determination of a safe and tolerable Recommended Phase 2 Dose (RP2D)

  2. Incidence of Dose Limiting Toxicities in in Dose Escalation and Cohort Expansion [ Time Frame: Approximately 2 years ]
    Determine safety and tolerability

  3. ORR as measured by stable disease (SD), partial response (PR), and complete response (CR) by radiographic assessment [ Time Frame: Approximately 2 years ]
    Disease response will be assessed using a combination of physical exam and imaging


Secondary Outcome Measures :
  1. Single-dose and steady-state Cmax of VRx-3996 and valganciclovir [ Time Frame: Through study completion, an average of 6 months ]
    PK assessment of both VRx-3996 and valganciclovir at 0, 1, 1.5, 2, 3, 5 and 7 hours post-dose on C1D1 and pre-dose on Day 1 of all following cycles

  2. Single-dose and steady-state AUC of VRx-3996 and valganciclovir [ Time Frame: Through study completion, an average of 6 months ]
    PK assessment of both VRx-3996 and valganciclovir at 0, 1, 1.5, 2, 3, 5 and 7 hours post-dose on C1D1 and pre-dose on Day 1 of all following cycles

  3. Steady-state Elimination half-life of VRx-3996 and valganciclovir [ Time Frame: Through study completion, an average of 6 months ]
    PK assessment of both VRx-3996 and valganciclovir at 0, 1, 1.5, 2, 3, 5 and 7 hours post-dose on C1D1 and pre-dose on Day 1 of all following cycles

  4. Time to response [ Time Frame: Approximately 6 months ]
    The time from the start of first study drug administration to the first overall tumor response observed for subjects who achieved a CR or PR

  5. Duration of response [ Time Frame: Up to approximately 2 years ]
    The time interval (days) from date of the first overall response (CR or PR; achieved after the study drug administration) to the date of disease progression

  6. Progression-free survival [ Time Frame: Up to approximately 2 years ]
    The interval between the date of first study drug administration and the date of PD or death, whichever is first reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397706


Contacts
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Contact: Robert McRae, Sr. Director, R&D Operations 858-400-8470 ClinicalTrials@Viracta.com

Locations
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United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Christine Duran, Study Coordinator    323-865-0371    duran_c@med.usc.edu   
Principal Investigator: Anil Tulpule, MD         
UC Irvine Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Michelle Perez    714-509-2414    michelrp@uci.edu   
Principal Investigator: Elizabeth Brem, MD         
United States, Colorado
University of Colorado Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Justin Massingill    720-848-0736    Justin.Massingill@ucdenver.edu   
Principal Investigator: Bradley Haverkos, MD         
United States, Georgia
Georgia Cancer Center at Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Crystal Durden    706-721-0660    CRDurden@augusta.edu   
Principal Investigator: Locke Bryan, MD         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Reem Karmali, MD, MS    312-695-0990    reem.karmali@northwestern.edu   
Principal Investigator: Reem Karmali, MD, MS         
Ruth M Rothstein CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mieoak Bahk    312-572-4543    mbahk@cookcountyhhs.org   
Principal Investigator: Paul Rubenstein, MD         
United States, Indiana
Indiana Blood and Marrow Transplantation Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Melanie Coleman    317-528-7298    melanie.coleman@franciscanalliance.org   
Principal Investigator: John Edwards, MD         
United States, Kansas
The University of Kansas Cancer Center and Medical Pavilion Recruiting
Westwood, Kansas, United States, 66205
Contact: Emily Kelly, Study Coordinator    913-588-2545    ekelly4@kumc.edu   
Principal Investigator: Anusha Vallurupalli, MD         
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Laura Clark, Study Nurse    410-502-5396    lclark53@jhmi.edu   
Principal Investigator: Richard Ambinder, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Vijayalakshmi Donthireddy, MD       vdonthi1@hfhs.org   
Contact: Marjorie Wood         
Principal Investigator: Vijayalakshmi Donthireddy, MD         
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Sabrina Kdiry    551-996-5952    Sabrina.Kdiry@hackensackmeridian.org   
Principal Investigator: Tatyana Feldman, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10019
Contact: Michelle Malanga    212-326-5720    mm4629@cumc.columbia.edu   
Principal Investigator: Ahmed Sawas, MD         
Weill Cornell Medical College - New York Presbyterian Hospital Recruiting
New York, New York, United States, 10065
Contact: Jennifer Bourke, Research Nurse    212-746-2844    jeb9097@med.cornell.edu   
Principal Investigator: Koen van Besien, MD, PhD         
United States, Ohio
The Ohio State University Wexner Medical Center James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Cynthia Jenkins    614-366-0855    cynthia.jenkins@osumc.edu   
Principal Investigator: Jonathon Brammer, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Ariel Kobylak    215-955-2810    Ariel.Kobylak@jefferson.edu   
Principal Investigator: Onder Alpdogan, MD         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Lovlei McKinnie    215-214-3173    Lovlei.McKinnie@fccc.edu   
Principal Investigator: Carlyn Tan, MD         
Brazil
Centro de Hematologia e Oncologia da Bahia (CEHON) Recruiting
Salvador, BA, Brazil, 40110-090
Contact: Débora Santos    +55 (71) 3281-6484    debora.santos@clinicacehon.com.br   
Principal Investigator: Ana Luzia Schriefer, MD         
Hospital do Cancer Mae de Deus Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Gabriela Alerico    +55 (51) 3234-4345    alerico.pesquisa@gmail.com   
Principal Investigator: Marcelo Capra, MD         
Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) Recruiting
Rio De Janeiro, RJ, Brazil, 20231-050
Contact: Tamara Tórmena    +55 (21) 3207-6585    tormena@inca.gov.br   
Principal Investigator: Adriana Sheliga, MD         
Real e Benemerita Associacao Portuguesa de Beneficencia Recruiting
São Paulo, SP, Brazil, 01321-001
Contact: Gislaine Mancin    +55 (11) 3505-6675    gislaine.mancin@bp.org.br   
Principal Investigator: Phillip Scheinberg, MD         
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Maris Sugino    +55 (11) 4573-7631    maris.sugino@hc.fm.usp.br   
Principal Investigator: Juliana Pereira, MD         
Hospital Santa Marcelina Recruiting
São Paulo, SP, Brazil, 08270-070
Contact: Carlos Opazo    +55 (11) 2217-3766    carlos.opazocpc@santamarcelina.org   
Principal Investigator: Jose Oliveira, MD         
Sponsors and Collaborators
Viracta Therapeutics, Inc.
Investigators
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Study Director: Marshelle Warren, MD, Chief Medical Officer Viracta Therapeutics, Inc.
More Information
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Additional Information:
Viracta Therapeutics, Inc.  This link exits the ClinicalTrials.gov site

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Responsible Party: Viracta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03397706     History of Changes
Other Study ID Numbers: VT3996-201
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Viracta Therapeutics, Inc.:
EBV+ post-transplant lymphoproliferative malignancy
EBV-associated lymphoproliferative disorders associated with acquired immunodeficiency including HIV-positive
Relapsed, refractory, EBV+ lymphoid malignancy

Additional relevant MeSH terms:
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Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Valganciclovir
Antiviral Agents
Anti-Infective Agents