NCT05011058 · OUTCOME
Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]
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*h/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 area under the concentration-time curve from time 0 to the last measurable plasma concentration
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. AUC0-t 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 AUC 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
| Group | Source 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
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 40 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 10 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 284 | 46.9 | Not reported | Not reported | Not reported |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 241 | 59.3 | Not reported | Not reported | Not reported |
|---|
Nanatinostat (Cycle 6 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 4 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 291 | 101.2 | Not reported | Not reported | Not reported |
|---|
M1 Metabolite (Cycle 1 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 40 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 10 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 1470 | 70.6 | Not reported | Not reported | Not reported |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 1410 | 56.8 | Not reported | Not reported | Not reported |
|---|
M1 Metabolite (Cycle 6 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 4 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 3750 | 42.2 | Not reported | Not reported | Not reported |
|---|
M2 Metabolite (Cycle 1 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 40 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 10 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 263 | 71.9 | Not reported | Not reported | Not reported |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 248 | 66.2 | Not reported | Not reported | Not reported |
|---|
M2 Metabolite (Cycle 6 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 4 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 335 | 168.2 | Not reported | Not reported | Not reported |
|---|
Ganciclovir (Cycle 1 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 40 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 21600 | 34.9 | Not reported | Not reported | Not reported |
|---|
Ganciclovir (Cycle 6 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 4 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in ng*h/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 33400 | 20.4 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 46.9
- value
- 284
- group Id
- OG001
- spread
- 59.3
- value
- 241
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- Nanatinostat (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 101.2
- value
- 291
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Nanatinostat (Cycle 6 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 70.6
- value
- 1470
- group Id
- OG001
- spread
- 56.8
- value
- 1410
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- M1 Metabolite (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 42.2
- value
- 3750
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- M1 Metabolite (Cycle 6 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 71.9
- value
- 263
- group Id
- OG001
- spread
- 66.2
- value
- 248
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- M2 Metabolite (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 168.2
- value
- 335
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- M2 Metabolite (Cycle 6 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 34.9
- value
- 21600
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Ganciclovir (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 20.4
- value
- 33400
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Ganciclovir (Cycle 6 Day 1)
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration
- dispersion Type
- Geometric Coefficient of Variation
- groups
- 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)
- 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. AUC0-t 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 AUC 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 Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
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