TriangleNCT00648739 · OUTCOME
Maximum Tolerated Dose (MTD) Of Samalizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m^2
- Interval / dispersion
- Not reported
- Time frame
- From first dose through 10 weeks after the last dose
What was measured
The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
Analysis population: All participants who received at least 1 dose of samalizumab.
Groups in this outcome
Samalizumab
All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
| Group | Source count |
|---|---|
| Samalizumab | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab | NA | Not reported | Not reported | Not reported | The MTD was not reached. The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns. |
Complete source fields
- classes
- categories
- measurements
- comment
- The MTD was not reached. The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns.
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 26
- units
- Participants
- description
- The MTD was to be defined as the dose level at which less than one-third of participants experienced a dose-limiting toxicity (DLT) during the first 28 days of treatment and immediately below the dose at which at least one-third of participants experienced a DLT. A DLT was defined as any Grade 3 or greater toxicity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 not related to the disease under study or its sequelae that occurred in the first 28 days after dosing in Cycle 1. The NCI CTCAE grading system for the organ of involvement was used to classify severity of adverse autoimmune reactions.
- groups
- description
- All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG000
- title
- Samalizumab
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of samalizumab.
- reporting Status
- POSTED
- time Frame
- From first dose through 10 weeks after the last dose
- title
- Maximum Tolerated Dose (MTD) Of Samalizumab
- type
- PRIMARY
- unit Of Measure
- mg/m^2
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice