TriangleNCT01849874 · OUTCOME
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
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
- From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)
What was measured
PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.
Analysis population: Analysis population included all randomized participants as of PCD (201 participants in MEK162 group and 102 participants in physician's choice group). In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
Groups in this outcome
MEK162
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
Physician's Choice
Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
| Group | Source count |
|---|---|
| MEK162 | 201 |
| Physician's Choice | 102 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 9.10 | Not reported | 7.29 | 11.30 | Not reported |
| Physician's Choice | 10.58 | Not reported | 9.20 | 14.52 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.29
- upper Limit
- 11.30
- value
- 9.10
- group Id
- OG001
- lower Limit
- 9.20
- upper Limit
- 14.52
- value
- 10.58
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
- id
- OG000
- title
- MEK162
- description
- Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
- id
- OG001
- title
- Physician's Choice
- param Type
- MEDIAN
- population Description
- Analysis population included all randomized participants as of PCD (201 participants in MEK162 group and 102 participants in physician's choice group). In the futility analysis based on PCD, the futility boundary was crossed, and therefore, no additional efficacy data was collected due to study early termination and no additional efficacy analyses were conducted.
- reporting Status
- POSTED
- time Frame
- From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)
- title
- Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice