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NCT03397706 · OUTCOME

Disease Control Rate

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies · Source last updated 2025-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 2 years

What was measured

Number (percentage) of patients with CR, PR, or stable disease (SD) per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)

Analysis population: Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Groups in this outcome

Phase 1b Dose Escalation Cohort 1

VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID

Phase 1b Dose Escalation Cohort 2a

VRx-3996: 5 mg BID valganciclovir: 450 mg BID

Phase 1b Dose Escalation Cohort 2b

VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID

Phase 1b Dose Escalation Cohort 2c

VRx-3996: 10 mg QD valganciclovir: 900 mg QD

Phase 1b Dose Escalation Cohort 3

VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD

Phase 2 Expansion - Capsule

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

Phase 2 Expansion - Tablet

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation Cohort 16
Phase 1b Dose Escalation Cohort 2a2
Phase 1b Dose Escalation Cohort 2b2
Phase 1b Dose Escalation Cohort 2c4
Phase 1b Dose Escalation Cohort 35
Phase 2 Expansion - Capsule23
Phase 2 Expansion - Tablet8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 14Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a2Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 34Not reportedNot reportedNot reportedNot reported
Phase 2 Expansion - Capsule12Not reportedNot reportedNot reportedNot reported
Phase 2 Expansion - Tablet3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      23
    7. group Id
      OG006
      value
      8
    units
    Participants
description
Number (percentage) of patients with CR, PR, or stable disease (SD) per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)
groups
  1. description
    VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    OG000
    title
    Phase 1b Dose Escalation Cohort 1
  2. description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    OG001
    title
    Phase 1b Dose Escalation Cohort 2a
  3. description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    OG002
    title
    Phase 1b Dose Escalation Cohort 2b
  4. description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    OG003
    title
    Phase 1b Dose Escalation Cohort 2c
  5. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG004
    title
    Phase 1b Dose Escalation Cohort 3
  6. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG005
    title
    Phase 2 Expansion - Capsule
  7. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG006
    title
    Phase 2 Expansion - Tablet
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Disease Control Rate
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice