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NCT03397706 · FLOW

Participant flow

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.

groups
  1. description
    Viracta (VRx)-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    FG000
    title
    Phase 1b Dose Escalation Cohort 1
  2. description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    FG001
    title
    Phase 1b Dose Escalation Cohort 2a
  3. description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    FG002
    title
    Phase 1b Dose Escalation Cohort 2b
  4. description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    FG003
    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
    FG004
    title
    Phase 1b Dose Escalation Cohort 3
  6. description
    VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week) and valganciclovir 900 mg QD
    id
    FG005
    title
    Phase 2 Dose Expansion - Capsule
  7. description
    VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week and valganciclovir 900 mg QD
    id
    FG006
    title
    Phase 2 Expansion - Tablet
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Starting valganciclovir dosage reductions based on creatinine clearance were allowed for participants with renal impairment.
Complete source fields
groups
  1. description
    Viracta (VRx)-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    FG000
    title
    Phase 1b Dose Escalation Cohort 1
  2. description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    FG001
    title
    Phase 1b Dose Escalation Cohort 2a
  3. description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    FG002
    title
    Phase 1b Dose Escalation Cohort 2b
  4. description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    FG003
    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
    FG004
    title
    Phase 1b Dose Escalation Cohort 3
  6. description
    VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week) and valganciclovir 900 mg QD
    id
    FG005
    title
    Phase 2 Dose Expansion - Capsule
  7. description
    VRx-3996 recommended Phase 2 dose \[RP2D\]: 20 mg once daily \[QD\] on Days 1 to 4/week and valganciclovir 900 mg QD
    id
    FG006
    title
    Phase 2 Expansion - Tablet
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        9
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        30
      7. group Id
        FG006
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Starting valganciclovir dosage reductions based on creatinine clearance were allowed for participants with renal impairment.

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Preserved source evidence · Not medical advice