TriangleNCT03389802 · OUTCOME
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 1
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
Based on the 3+3 design, the MTD of APX005M was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT, and the next higher dose level was determined to be too toxic. A total of 12 subjects were to be treated at the MTD/RP2D to further define the toxicity profile. Stratum 1 consisted of patients with recurrent or refractory primary malignant central nervous system tumors.
Analysis population: Patients who were enrolled on Stratum 1 and evaluable for dose-finding assessment were used to determine the MTD for Stratum 1. Of 20 eligible patients enrolled on Stratum 1, 2 were not evaluable for dose-finding assessment due to early progressive disease (these 2 participants received less than 2 doses of treatment). The remaining 18 patients were used to determine the MTD/RP2D for Stratum 1.
Groups in this outcome
Stratum 1
Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). 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 1 | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 | 0.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- Based on the 3+3 design, the MTD of APX005M was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT, and the next higher dose level was determined to be too toxic. A total of 12 subjects were to be treated at the MTD/RP2D to further define the toxicity profile. Stratum 1 consisted of patients with recurrent or refractory primary malignant central nervous system tumors.
- groups
- description
- Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). 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 1
- param Type
- NUMBER
- population Description
- Patients who were enrolled on Stratum 1 and evaluable for dose-finding assessment were used to determine the MTD for Stratum 1. Of 20 eligible patients enrolled on Stratum 1, 2 were not evaluable for dose-finding assessment due to early progressive disease (these 2 participants received less than 2 doses of treatment). The remaining 18 patients were used to determine the MTD/RP2D for Stratum 1.
- 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 1
- type
- PRIMARY
- unit Of Measure
- mg/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice