TriangleNCT02365597 · OUTCOME
Main Study: Progression-free Survival (PFS)
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
Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: The population included participants who received at least 1 dose of study drug.
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 | 33 |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 78 |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: Regimen 1: Erdafitinib 10 Milligrams (mg)/ 12 mg | 4.80 | Not reported | 1.1 | 25.3 | Not reported |
| Main Study: Regimen 2: Erdafitinib 6 mg/ 8 mg | 5.26 | Not reported | 0.4 | 57.9 | Not reported |
| Main Study: Regimen 3: Erdafitinib 8 mg/ 9 mg | 5.52 | Not reported | 0.0 | 51.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 25.3
- value
- 4.80
- group Id
- OG001
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 5.26
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 51.5
- value
- 5.52
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 101
- units
- Participants
- description
- Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death due to any cause, whichever occurs first, regardless of the use of subsequent anticancer therapy. As per RECIST version 1.1, CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- 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.
- reporting Status
- POSTED
- time Frame
- From screening up to 6 years 2 months
- title
- Main Study: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice