TriangleNCT02065687 · OUTCOME
Overall Survival (OS) (Phase II)
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 date of study entry to time of death or the date of last contact, assessed up to 5 years.
What was measured
The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
Analysis population: All patients
Groups in this outcome
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Paclitaxel, Carboplatin, Placebo)
Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 234 |
| Arm II (Paclitaxel, Carboplatin, Placebo) | 235 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 34.6 | Not reported | 28.0 | 50.1 | Not reported |
| Arm II (Paclitaxel, Carboplatin, Placebo) | 30.4 | Not reported | 24.6 | 37.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.0
- upper Limit
- 50.1
- value
- 34.6
- group Id
- OG001
- lower Limit
- 24.6
- upper Limit
- 37.8
- value
- 30.4
- denoms
- counts
- group Id
- OG000
- value
- 234
- group Id
- OG001
- value
- 235
- units
- Participants
- description
- The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride)
- description
- Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Paclitaxel, Carboplatin, Placebo)
- param Type
- MEDIAN
- population Description
- All patients
- reporting Status
- POSTED
- time Frame
- From date of study entry to time of death or the date of last contact, assessed up to 5 years.
- title
- Overall Survival (OS) (Phase II)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice