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NCT03397706 · OUTCOME

Time to Response

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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 2 years

What was measured

Interval of time from the start of study drug treatment to the first documentation of CR or PR per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)

Analysis population: Patients who achieved a PR or CR. 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 13
Phase 1b Dose Escalation Cohort 2a2
Phase 1b Dose Escalation Cohort 2b1
Phase 1b Dose Escalation Cohort 2c0
Phase 1b Dose Escalation Cohort 33
Phase 2 Expansion - Capsule7
Phase 2 Expansion - Tablet2

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 1NANot reported33.0NAThe median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 2a52.5Not reported51.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 2bNANot reported50.0NAThe median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 3NANot reported57.0NAThe median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
Phase 2 Expansion - Capsule162.0Not reported58.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 2 Expansion - TabletNANot reported58.0NAThe median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        33.0
        upper Limit
        NA
        value
        NA
      2. comment
        The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        51.0
        upper Limit
        NA
        value
        52.5
      3. comment
        The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        50.0
        upper Limit
        NA
        value
        NA
      4. comment
        The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        57.0
        upper Limit
        NA
        value
        NA
      5. comment
        The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
        group Id
        OG005
        lower Limit
        58.0
        upper Limit
        NA
        value
        162.0
      6. comment
        The median and upper bound of the 95% confidence interval were not reached due to insufficient number of participants with events.
        group Id
        OG006
        lower Limit
        58.0
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      7
    7. group Id
      OG006
      value
      2
    units
    Participants
description
Interval of time from the start of study drug treatment to the first documentation of CR or PR per Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68)
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Patients who achieved a PR or CR. 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
Time to Response
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice