TriangleNCT03397706 · OUTCOME
Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1 (28 days)
What was measured
Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria: * Grade 4 anemia unexplained by underlying disease * Grade 4 febrile neutropenia * Grade 4 neutropenia lasting \>5 days * Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration * Grade 4 or higher tumor lysis syndrome * Grade 3 or higher thrombocytopenia (with or without bleeding) * Any requirement for platelet transfusion * Grade 3 or higher non-hematologic toxicity despite adequate supportive care * Results in a dose hold of \>7 consecutive days
Analysis population: Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. 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 (RP2D)
VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
| Group | Source count |
|---|---|
| Phase 1b Dose Escalation Cohort 1 | 7 |
| Phase 1b Dose Escalation Cohort 2a | 5 |
| Phase 1b Dose Escalation Cohort 2b | 4 |
| Phase 1b Dose Escalation Cohort 2c | 4 |
| Phase 1b Dose Escalation Cohort 3 (RP2D) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b Dose Escalation Cohort 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b Dose Escalation Cohort 2a | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b Dose Escalation Cohort 2b | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b Dose Escalation Cohort 2c | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1b Dose Escalation Cohort 3 (RP2D) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria: * Grade 4 anemia unexplained by underlying disease * Grade 4 febrile neutropenia * Grade 4 neutropenia lasting \>5 days * Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration * Grade 4 or higher tumor lysis syndrome * Grade 3 or higher thrombocytopenia (with or without bleeding) * Any requirement for platelet transfusion * Grade 3 or higher non-hematologic toxicity despite adequate supportive care * Results in a dose hold of \>7 consecutive days
- 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 (RP2D)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (28 days)
- title
- Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice