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NCT03397706 · OUTCOME

Overall Survival

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 date of first study drug treatment to date of death, for any reason (patients without documentation of death at the time of analysis were censored at the date the patient was last known to be alive)

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 days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 1227.0Not reported122.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 2a578.0Not reported486.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 2bNANot reported328.0NAThe 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 2c168.5Not reported32.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 1b Dose Escalation Cohort 3496.0Not reported49.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 2 Expansion - Capsule801.0Not reported315.0NAThe upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
Phase 2 Expansion - TabletNANot reported106.0NAThe 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 upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        122.0
        upper Limit
        NA
        value
        227.0
      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
        486.0
        upper Limit
        NA
        value
        578.0
      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
        328.0
        upper Limit
        NA
        value
        NA
      4. comment
        The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        32.0
        upper Limit
        NA
        value
        168.5
      5. comment
        The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
        group Id
        OG004
        lower Limit
        49.0
        upper Limit
        NA
        value
        496.0
      6. 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
        315.0
        upper Limit
        NA
        value
        801.0
      7. 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
        106.0
        upper Limit
        NA
        value
        NA
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
Interval of time from date of first study drug treatment to date of death, for any reason (patients without documentation of death at the time of analysis were censored at the date the patient was last known to be alive)
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
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
Overall Survival
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice