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History of Changes for Study: NCT03397706
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies
Latest version (submitted July 26, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 10, 2018 None (earliest Version on record)
2 January 12, 2018 Recruitment Status, Contacts/Locations and Study Status
3 February 20, 2018 Contacts/Locations and Study Status
4 April 9, 2018 Contacts/Locations and Study Status
5 May 18, 2018 Study Status and Contacts/Locations
6 May 21, 2018 Contacts/Locations and Study Status
7 May 21, 2018 Contacts/Locations and Study Status
8 June 14, 2018 Contacts/Locations and Study Status
9 October 8, 2018 Contacts/Locations and Study Status
10 October 30, 2018 Contacts/Locations and Study Status
11 January 7, 2019 Study Status and Contacts/Locations
12 January 8, 2019 Contacts/Locations and Study Status
13 September 30, 2019 Study Status and Contacts/Locations
14 May 19, 2020 Contacts/Locations, Study Status, Outcome Measures, Eligibility, Study Design and Conditions
15 June 26, 2020 Contacts/Locations and Study Status
16 July 8, 2020 Contacts/Locations and Study Status
17 October 8, 2020 Contacts/Locations and Study Status
18 October 21, 2020 Contacts/Locations and Study Status
19 November 3, 2020 Contacts/Locations and Study Status
20 May 7, 2021 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Study Design and Study Description
21 July 12, 2021 Contacts/Locations and Study Status
22 July 26, 2021 Study Status
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Study NCT03397706
Submitted Date:  January 10, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: VT3996-201
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Not yet recruiting
Study Start: January 2018
Primary Completion: August 2019 [Anticipated]
Study Completion: August 2019 [Anticipated]
First Submitted: December 20, 2017
First Submitted that
Met QC Criteria:
January 10, 2018
First Posted: January 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
January 10, 2018
Last Update Posted: January 12, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Viracta Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Epstein-Barr Virus Associated Lymphoma
Lymphoproliferative Disorders
Keywords: EBV+ post-transplant lymphoproliferative malignancy
EBV-associated lymphoproliferative disorders associated with acquired immunodeficiency including HIV-positive
Relapsed, refractory, EBV+ lymphoid malignancy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment

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

Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 45 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Miriam Cruz, VP Clinical Operations
Telephone: 858-771-4187
Email: mcruz@viracta.com
Study Officials: Marshelle Warren, MD, Chief Medical Officer
Study Director
Viracta Therapeutics, Inc.
Locations: United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links: Description: Viracta Therapeutics, Inc.
Available IPD/Information:

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