TriangleNCT03397706 · OUTCOME
Progression-Free Survival
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 the date of first study drug administration to the documented date of disease progression or death, whichever occurred first, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion)
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 | Source count |
|---|---|
| Phase 1b Dose Escalation Cohort 1 | 6 |
| Phase 1b Dose Escalation Cohort 2a | 2 |
| Phase 1b Dose Escalation Cohort 2b | 2 |
| Phase 1b Dose Escalation Cohort 2c | 4 |
| Phase 1b Dose Escalation Cohort 3 | 5 |
| Phase 2 Expansion - Capsule | 23 |
| Phase 2 Expansion - Tablet | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b Dose Escalation Cohort 1 | 209.0 | Not reported | 57.0 | NA | The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events. |
| Phase 1b Dose Escalation Cohort 2a | 168.0 | Not reported | 87.0 | NA | The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events. |
| Phase 1b Dose Escalation Cohort 2b | 107.5 | Not reported | 53.0 | NA | The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events. |
| Phase 1b Dose Escalation Cohort 2c | 55.5 | Not reported | 15.0 | NA | The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events. |
| Phase 1b Dose Escalation Cohort 3 | 185.0 | Not reported | 10.0 | NA | The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events. |
| Phase 2 Expansion - Capsule | 66.0 | Not reported | 56.0 | 220.0 | Not reported |
| Phase 2 Expansion - Tablet | 52.5 | Not reported | 34.0 | 114.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 57.0
- upper Limit
- NA
- value
- 209.0
- 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
- 87.0
- upper Limit
- NA
- value
- 168.0
- comment
- The upper bound of the 95% confidence interval was not reached due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 53.0
- upper Limit
- NA
- value
- 107.5
- 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
- 15.0
- upper Limit
- NA
- value
- 55.5
- 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
- 10.0
- upper Limit
- NA
- value
- 185.0
- group Id
- OG005
- lower Limit
- 56.0
- upper Limit
- 220.0
- value
- 66.0
- group Id
- OG006
- lower Limit
- 34.0
- upper Limit
- 114.0
- value
- 52.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 23
- group Id
- OG006
- value
- 8
- units
- Participants
- description
- Interval of time from the date of first study drug administration to the documented date of disease progression or death, whichever occurred first, where disease progression is defined by Lugano 2014 criteria (Cheson BD et al. J Clin Oncology 2014;32(27):3059-68) as progressive metabolic disease (increase in fluorodeoxyglucose \[FDG\] uptake from baseline or new FDG-avid foci consistent with lymphoma) or progressive radiologic response (increase in the product of perpendicular diameters of a single node by ≥ 50% or emergence of a new lesion)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
- id
- OG000
- title
- Phase 1b Dose Escalation Cohort 1
- description
- VRx-3996: 5 mg BID valganciclovir: 450 mg BID
- id
- OG001
- title
- Phase 1b Dose Escalation Cohort 2a
- description
- VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
- id
- OG002
- title
- Phase 1b Dose Escalation Cohort 2b
- description
- VRx-3996: 10 mg QD valganciclovir: 900 mg QD
- id
- OG003
- title
- Phase 1b Dose Escalation Cohort 2c
- 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
- 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
- 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
- Progression-Free Survival
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice