TriangleNCT02365597 · OUTCOME
Main Study: Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From screening up to 6 years 2 months
What was measured
DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Analysis population: The population included participants who received at least 1 dose of study drug and who had CR or PR.
Groups in this outcome
Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
| Group | Source count |
|---|---|
| Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | 7 |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 27 |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | 13.37 | Not reported | 4.2 | 19.4 | Not reported |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 4.90 | Not reported | 2.5 | 56.5 | Not reported |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 5.98 | Not reported | 2.4 | 50.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 19.4
- value
- 13.37
- group Id
- OG001
- lower Limit
- 2.5
- upper Limit
- 56.5
- value
- 4.90
- group Id
- OG002
- lower Limit
- 2.4
- upper Limit
- 50.2
- value
- 5.98
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 40
- units
- Participants
- description
- DOR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression or date of death, whatever the cause based on the RECIST version 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
- dispersion Type
- Full Range
- groups
- description
- Participants received single dose of erdafitinib 10 mg tablet, orally, once daily, starting from Day 1 through Day 7 and from Day 15 through Day 21 and so on, that is 7-day on and off in each subsequent 28-day cycles starting from Cycle 1. Based on serum phosphate (PO4) levels, there was an option to up-titrate erdafitinib dose to 12 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG000
- title
- Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg
- description
- Participants received single dose of erdafitinib 6 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 8 mg, orally, once daily starting from Cycle 2 Day 1 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG001
- title
- Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg
- description
- Participants received single dose of erdafitinib 8 mg tablet, orally, once daily, starting from Day 1 through Day 28 in each subsequent 28-day cycles starting from Cycle 1. Based on serum PO4 levels, there was an option to up-titrate erdafitinib dose to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity, or any other reason for treatment discontinuation.
- id
- OG002
- title
- Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg
- param Type
- MEDIAN
- population Description
- The population included participants who received at least 1 dose of study drug and who had CR or PR.
- reporting Status
- POSTED
- time Frame
- From screening up to 6 years 2 months
- title
- Main Study: Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice