TriangleNCT02535312 · OUTCOME
Progression-free Survival
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 start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 year
What was measured
Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Analysis population: Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
Groups in this outcome
Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I
Patients receive 50, 75 or 100 mg/day of TRC102 PO QD on days 1-4, 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
Arm B (TRC102, Pemetrexed Disodium) - Phase II
Patients receive 50 mg/day of TRC102 PO QD on days 1-4 and 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
| Group | Source count |
|---|---|
| Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I | 16 |
| Arm B (TRC102, Pemetrexed Disodium) - Phase II | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I | 7.1 | Not reported | 1.4 | 14.4 | Not reported |
| Arm B (TRC102, Pemetrexed Disodium) - Phase II | 3.8 | Not reported | 1.4 | 6.5 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.08
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.08
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 14.4
- value
- 7.1
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 6.5
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 50, 75 or 100 mg/day of TRC102 PO QD on days 1-4, 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
- id
- OG000
- title
- Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I
- description
- Patients receive 50 mg/day of TRC102 PO QD on days 1-4 and 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
- id
- OG001
- title
- Arm B (TRC102, Pemetrexed Disodium) - Phase II
- param Type
- MEDIAN
- population Description
- Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
- reporting Status
- POSTED
- time Frame
- From start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 year
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice