TriangleNCT03436732 · OUTCOME
Maximum Tolerated Dose (MTD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Day 21
What was measured
MTD is defined as the highest tested dose of LMB-100 and SEL-110 at which no more than 1 of 6 subjects experience a dose limiting toxicity. A dose limiting toxicity is defined as any of the following: Grade 4 neutropenia for a minimum duration of 7 days. Grade 4 thrombocytopenia (≤25.0 x 10(9) cells/L), Grade 3 thrombocytopenia associated with bleeding episodes, and Grade 4 anemia. Grade ≥3 non-hematological toxicity with the exception of Alopecia (any grade), Grade 3 nausea and vomiting lasting \> 48 hours despite appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration, and laboratory values of ≥ grade 3 that are judged not clinically significant by the investigator. Any other drug related toxicity considered significant enough to be qualified as a DLT in the opinion of the principal investigator. Inability to start cycle 2 within 3 weeks after completing cycle 1 due to drug-related adverse events.
Analysis population: MTD was not found because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.
Groups in this outcome
1/Dose Escalation
Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
| Group | Source count |
|---|---|
| 1/Dose Escalation | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- MTD is defined as the highest tested dose of LMB-100 and SEL-110 at which no more than 1 of 6 subjects experience a dose limiting toxicity. A dose limiting toxicity is defined as any of the following: Grade 4 neutropenia for a minimum duration of 7 days. Grade 4 thrombocytopenia (≤25.0 x 10(9) cells/L), Grade 3 thrombocytopenia associated with bleeding episodes, and Grade 4 anemia. Grade ≥3 non-hematological toxicity with the exception of Alopecia (any grade), Grade 3 nausea and vomiting lasting \> 48 hours despite appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration, and laboratory values of ≥ grade 3 that are judged not clinically significant by the investigator. Any other drug related toxicity considered significant enough to be qualified as a DLT in the opinion of the principal investigator. Inability to start cycle 2 within 3 weeks after completing cycle 1 due to drug-related adverse events.
- groups
- description
- Dose escalation - patients with mesothelioma treated with LMB-100+SEL-110 at escalating doses LMB-100: administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles SEL-110: administered on day 1 of each cycle for up to 4 cycles
- id
- OG000
- title
- 1/Dose Escalation
- population Description
- MTD was not found because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.
- reporting Status
- POSTED
- time Frame
- Day 21
- title
- Maximum Tolerated Dose (MTD)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice