TriangleNCT02065687 · OUTCOME
Overall Survival (OS) (Phase II and III)
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. 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. 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 and III)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice