TriangleNCT04582539 · OUTCOME
Maximum Tolerated Dose (MTD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligrams
- Interval / dispersion
- Not reported
- Time frame
- up to Day 28
What was measured
The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
Analysis population: Full Analysis Set-MDS
Groups in this outcome
All Participants
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib QD administered as a monotherapy for up to 6 months.
| Group | Source count |
|---|---|
| All Participants | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | NA | Not reported | Not reported | Not reported | The maximum sample size for each dose level was 9. Given that there were 2 DLT-evaluable participants at the 600 mg QD dose level and 1 DLT was observed, the dose should have been de-escalated. As a result, the dose escalation was incomplete at the time of study termination, and the MTD could not be determined since the stopping rule had not been met. |
Complete source fields
- classes
- categories
- measurements
- comment
- The maximum sample size for each dose level was 9. Given that there were 2 DLT-evaluable participants at the 600 mg QD dose level and 1 DLT was observed, the dose should have been de-escalated. As a result, the dose escalation was incomplete at the time of study termination, and the MTD could not be determined since the stopping rule had not been met.
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
- groups
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib QD administered as a monotherapy for up to 6 months.
- id
- OG000
- title
- All Participants
- param Type
- NUMBER
- population Description
- Full Analysis Set-MDS
- reporting Status
- POSTED
- time Frame
- up to Day 28
- title
- Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- milligrams
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice