TriangleNCT02300610 · OUTCOME
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
- 95% Confidence Interval
- Time frame
- 14 months
What was measured
Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Analysis population: All Participants.
Groups in this outcome
Dose Escalation: Level 1 Dose
Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
Dose Escalation: Level 2 Dose
Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
Dose Expansion
Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
| Group | Source count |
|---|---|
| Dose Escalation: Level 1 Dose | 3 |
| Dose Escalation: Level 2 Dose | 3 |
| Dose Expansion | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Level 1 Dose | 3.81 | Not reported | 1.45 | 4.14 | Not reported |
| Dose Escalation: Level 2 Dose | 14.63 | Not reported | 13.71 | 15.88 | Not reported |
| Dose Expansion | 7.68 | Not reported | 6.25 | 10.03 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.45
- upper Limit
- 4.14
- value
- 3.81
- group Id
- OG001
- lower Limit
- 13.71
- upper Limit
- 15.88
- value
- 14.63
- group Id
- OG002
- lower Limit
- 6.25
- upper Limit
- 10.03
- value
- 7.68
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).
- id
- OG000
- title
- Dose Escalation: Level 1 Dose
- description
- Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).
- id
- OG001
- title
- Dose Escalation: Level 2 Dose
- description
- Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.
- id
- OG002
- title
- Dose Expansion
- param Type
- MEDIAN
- population Description
- All Participants.
- reporting Status
- POSTED
- time Frame
- 14 months
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice