TriangleNCT01849874 · OUTCOME
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 the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
What was measured
DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
Analysis population: Analysis population included all randomized participants with measurable disease at baseline per BICR with response ongoing as of PCD (23 in MEK162 group and 8 in physician's choice group). Here, "Number of Participants Analyzed" signifies number of participants evaluable for DOR. 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 | 23 |
| Physician's Choice | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 8.05 | Not reported | 0.03 | 11.99 | Not reported |
| Physician's Choice | 6.67 | Not reported | 0.03 | 9.69 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 11.99
- value
- 8.05
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 9.69
- value
- 6.67
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.
- dispersion Type
- Full Range
- 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 with measurable disease at baseline per BICR with response ongoing as of PCD (23 in MEK162 group and 8 in physician's choice group). Here, "Number of Participants Analyzed" signifies number of participants evaluable for DOR. 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 the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice