NCT05011058 · OUTCOME
Pharmacokinetic (PK) Parameter - Half-Life [t1/2]
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
- MEAN
- Unit
- hours
- Interval / dispersion
- Standard Deviation
- 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 time required to reduce plasma concentration by 50% after study drug administration
Analysis population: Defined as all patients who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. This stricter requirement explains why, for example, the overall number analyzed for t1/2 (ie, 16) is less than the overall number analyzed for the other PK parameters (ie, 50). As prespecified by the analysis plan, combination therapy cohorts were combined since t1/2 for small molecules should not be affected by lymphoma subtype.
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) | 12 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 4 |
|---|
Reported measurements
Nanatinostat (Cycle 1 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 12 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 4 |
|---|
Values in hours · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 1.52 | 0.464 | Not reported | Not reported | Not reported |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 2.17 | 0.503 | Not reported | Not reported | Not reported |
|---|
Nanatinostat (Cycle 6 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 1 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in hours · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 1.21 | 0 | Not reported | Not reported | Not reported |
|---|
Ganciclovir (Cycle 1 Day 1)
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 9 |
|---|
| Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma) | 0 |
|---|
Values in hours · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 3.41 | 1.34 | 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 hours · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination Therapy (EBV-Associated Lymphoid Malignancy) | 5.31 | 2.36 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.464
- value
- 1.52
- group Id
- OG001
- spread
- 0.503
- value
- 2.17
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Nanatinostat (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 0
- value
- 1.21
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Nanatinostat (Cycle 6 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 1.34
- value
- 3.41
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Ganciclovir (Cycle 1 Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 2.36
- value
- 5.31
- 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
- 12
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Defined as the time required to reduce plasma concentration by 50% after study drug administration
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Defined as all patients who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. This stricter requirement explains why, for example, the overall number analyzed for t1/2 (ie, 16) is less than the overall number analyzed for the other PK parameters (ie, 50). As prespecified by the analysis plan, combination therapy cohorts were combined since t1/2 for small molecules should not be affected by lymphoma subtype.
- 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 - Half-Life [t1/2]
- type
- SECONDARY
- unit Of Measure
- hours
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