TriangleNCT02514239 · OUTCOME
The Maximum Tolerated Dose (MTD) of BI 836909
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Microgram Per Day (μg/d)
- Interval / dispersion
- Not reported
- Time frame
- Cycle 1, up to 6 weeks.
What was measured
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Analysis population: MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
Groups in this outcome
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
| Group | Source count |
|---|---|
| Intravenous Infusion of BI 836909 (Total Dose Escalation) | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intravenous Infusion of BI 836909 (Total Dose Escalation) | 400 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 400
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
- groups
- description
- BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
- id
- OG000
- title
- Intravenous Infusion of BI 836909 (Total Dose Escalation)
- param Type
- NUMBER
- population Description
- MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
- reporting Status
- POSTED
- time Frame
- Cycle 1, up to 6 weeks.
- title
- The Maximum Tolerated Dose (MTD) of BI 836909
- type
- PRIMARY
- unit Of Measure
- Microgram Per Day (μg/d)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice