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NCT05011058 · OUTCOME

Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas · Source last updated 2025-07-28

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

What was measured

Defined as the peak plasma concentration \[Cmax\] after study drug administration

Analysis population: Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Cmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Cmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.

Groups in this outcome

Combination Therapy (EBV-Associated Lymphoid Malignancy)

Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD

Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)

Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week

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

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)40
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)10

Reported measurements

Nanatinostat (Cycle 1 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)40
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)10
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)11668.9Not reportedNot reportedNot reported
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)10583.0Not reportedNot reportedNot reported
Nanatinostat (Cycle 6 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)4
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)0
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)134121.3Not reportedNot reportedNot reported
M1 Metabolite (Cycle 1 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)40
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)10
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)43549.6Not reportedNot reportedNot reported
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)39348.3Not reportedNot reportedNot reported
M1 Metabolite (Cycle 6 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)4
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)0
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)42764.6Not reportedNot reportedNot reported
M2 Metabolite (Cycle 1 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)40
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)10
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)75.156.5Not reportedNot reportedNot reported
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)65.864.3Not reportedNot reportedNot reported
M2 Metabolite (Cycle 6 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)4
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)0
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)82.879.0Not reportedNot reportedNot reported
Ganciclovir (Cycle 1 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)40
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)0
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)635035.7Not reportedNot reportedNot reported
Ganciclovir (Cycle 6 Day 1)

Analysis denominator · Participants

GroupSource count
Combination Therapy (EBV-Associated Lymphoid Malignancy)4
Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)0
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Combination Therapy (EBV-Associated Lymphoid Malignancy)539059.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.9
        value
        116
      2. group Id
        OG001
        spread
        83.0
        value
        105
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Nanatinostat (Cycle 1 Day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        121.3
        value
        134
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Nanatinostat (Cycle 6 Day 1)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.6
        value
        435
      2. group Id
        OG001
        spread
        48.3
        value
        393
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    M1 Metabolite (Cycle 1 Day 1)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.6
        value
        427
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M1 Metabolite (Cycle 6 Day 1)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.5
        value
        75.1
      2. group Id
        OG001
        spread
        64.3
        value
        65.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    M2 Metabolite (Cycle 1 Day 1)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        79.0
        value
        82.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    M2 Metabolite (Cycle 6 Day 1)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.7
        value
        6350
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Ganciclovir (Cycle 1 Day 1)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.6
        value
        5390
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Ganciclovir (Cycle 6 Day 1)
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Defined as the peak plasma concentration \[Cmax\] after study drug administration
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD
    id
    OG000
    title
    Combination Therapy (EBV-Associated Lymphoid Malignancy)
  2. description
    Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week
    id
    OG001
    title
    Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)
param Type
GEOMETRIC_MEAN
population Description
Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Cmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Cmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)
title
Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice