TriangleNCT03390504 · OUTCOME
Oral Clearance (CL/F) of Erdafitinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Liter per hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)
What was measured
Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
Analysis population: Pharmacokinetic-evaluable analysis set included all randomized participants who received at least 1 dose of erdafitinib and had at least 1 evaluable pharmacokinetic sample obtained posttreatment. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
Groups in this outcome
Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg
Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\[L\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg
Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
| Group | Source count |
|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | 126 |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | 149 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg | NA | NA | Not reported | Not reported | Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using non-compartmental analysis (NCA) method. |
| Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg | NA | NA | Not reported | Not reported | Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using NCA method. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using non-compartmental analysis (NCA) method.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive CL/F using NCA method.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 149
- units
- Participants
- description
- Clearance was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\[L\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
- id
- OG000
- title
- Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg
- description
- Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
- id
- OG001
- title
- Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg
- param Type
- MEAN
- population Description
- Pharmacokinetic-evaluable analysis set included all randomized participants who received at least 1 dose of erdafitinib and had at least 1 evaluable pharmacokinetic sample obtained posttreatment. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle was of 21 days)
- title
- Oral Clearance (CL/F) of Erdafitinib
- type
- SECONDARY
- unit Of Measure
- Liter per hour
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice