TriangleNCT03389802 · OUTCOME
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/kg
- Interval / dispersion
- Not reported
- Time frame
- 6 weeks (first 2 courses of treatment)
What was measured
The starting dose level for Stratum 2 was one dose level below the RP2D determined in Stratum 1. If there were no dose-limiting toxicities in the first 3 patients enrolled on Stratum 2, then we escalated to the Stratum 1 RP2D and could treat 6 diffuse intrinsic pontine glioma (DIPG) patients simultaneously. The RP2D was defined as the dose level at which 6 patients were treated with no more than one dose-limiting toxicity. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Analysis population: Patients who were enrolled on Stratum 2 and were evaluable for dose-finding assessment were used to determine the MTD for Stratum 2. Of 11 patients enrolled on Stratum 2, all were evaluable for dose-finding assessment and used to determine the MTD for Stratum 2.
Groups in this outcome
Stratum 2
Newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) patients treated with APX005M. The dose levels studied were 0.3 mg/kg (dose level 2) and 0.6 mg/kg (dose level 3). Dose level 2 was selected as the starting dose level for Stratum 2 as it was one dose level lower than the Stratum 1 MTD/RP2D. APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.
| Group | Source count |
|---|---|
| Stratum 2 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2 | 0.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- The starting dose level for Stratum 2 was one dose level below the RP2D determined in Stratum 1. If there were no dose-limiting toxicities in the first 3 patients enrolled on Stratum 2, then we escalated to the Stratum 1 RP2D and could treat 6 diffuse intrinsic pontine glioma (DIPG) patients simultaneously. The RP2D was defined as the dose level at which 6 patients were treated with no more than one dose-limiting toxicity. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
- groups
- description
- Newly diagnosed diffuse intrinsic pontine gliomas (DIPGs) patients treated with APX005M. The dose levels studied were 0.3 mg/kg (dose level 2) and 0.6 mg/kg (dose level 3). Dose level 2 was selected as the starting dose level for Stratum 2 as it was one dose level lower than the Stratum 1 MTD/RP2D. APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.
- id
- OG000
- title
- Stratum 2
- param Type
- NUMBER
- population Description
- Patients who were enrolled on Stratum 2 and were evaluable for dose-finding assessment were used to determine the MTD for Stratum 2. Of 11 patients enrolled on Stratum 2, all were evaluable for dose-finding assessment and used to determine the MTD for Stratum 2.
- reporting Status
- POSTED
- time Frame
- 6 weeks (first 2 courses of treatment)
- title
- Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2
- type
- PRIMARY
- unit Of Measure
- mg/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice