TriangleNCT01401530 · OUTCOME
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- ug/kg/day
- Interval / dispersion
- Not reported
- Time frame
- For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
What was measured
The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.
Analysis population: DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT.
Groups in this outcome
Denileukin Diftitox
Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
| Group | Source count |
|---|---|
| Denileukin Diftitox | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Denileukin Diftitox | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.
- groups
- description
- Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
- id
- OG000
- title
- Denileukin Diftitox
- param Type
- NUMBER
- population Description
- DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT.
- reporting Status
- POSTED
- time Frame
- For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
- title
- Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
- type
- PRIMARY
- unit Of Measure
- ug/kg/day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice