TriangleNCT02393248 · OUTCOME
EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours*nanomoles
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
What was measured
EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
Analysis population: PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
Groups in this outcome
Parts 1 and 2: Intermittent or Continuous Pemigatinib
Participant self-administered intermittent pemigatinib once daily (QD) or continuous pemigatinib QD or twice daily (BID). Intermittent dosing: participants self-administered oral pemigatinib 1/2/4 milligrams (mg), 6 mg, 9 mg, 13.5 mg, or 20 mg once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg, 13.5 mg, or 20 mg QD on Days 1 through 21 of each 21-day cycle in Part 1 or Part 2. Participants self-administered oral pemigatinib 7.5 mg or 10 mg BID on Days 1 through 21 of each 21-day cycle in Part 1.
| Group | Source count |
|---|---|
| Parts 1 and 2: Intermittent or Continuous Pemigatinib | 93 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Parts 1 and 2: Intermittent or Continuous Pemigatinib | 1573 | 21.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.6
- value
- 1573
- denoms
- counts
- group Id
- OG000
- value
- 93
- units
- Participants
- description
- EC50 was defined as the pemigatinib steady-state area under the plasma or serum concentration-time curve that increases 50% of serum phosphate.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participant self-administered intermittent pemigatinib once daily (QD) or continuous pemigatinib QD or twice daily (BID). Intermittent dosing: participants self-administered oral pemigatinib 1/2/4 milligrams (mg), 6 mg, 9 mg, 13.5 mg, or 20 mg once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg, 13.5 mg, or 20 mg QD on Days 1 through 21 of each 21-day cycle in Part 1 or Part 2. Participants self-administered oral pemigatinib 7.5 mg or 10 mg BID on Days 1 through 21 of each 21-day cycle in Part 1.
- id
- OG000
- title
- Parts 1 and 2: Intermittent or Continuous Pemigatinib
- param Type
- GEOMETRIC_MEAN
- population Description
- PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.
- reporting Status
- POSTED
- time Frame
- predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles
- title
- EC50 Following Once Daily Dosing of Pemigatinib as Monotherapy in Parts 1 and 2
- type
- PRIMARY
- unit Of Measure
- hours*nanomoles
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice