TriangleNCT01849874 · OUTCOME
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization until disease progression or death (up to 24 months)
What was measured
ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
Analysis population: Analysis population included all randomized participants with measurable disease at baseline per BICR as of PCD (198 participants in MEK162 group and 101 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 | 198 |
| Physician's Choice | 101 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 16 | Not reported | Not reported | Not reported | Not reported |
| Physician's Choice | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 101
- units
- Participants
- description
- ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.
- 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
- NUMBER
- population Description
- Analysis population included all randomized participants with measurable disease at baseline per BICR as of PCD (198 participants in MEK162 group and 101 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 disease progression or death (up to 24 months)
- title
- Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice