TriangleNCT04111107 · OUTCOME
Progression Free Survival Ratio
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ratio
- Interval / dispersion
- Full Range
- Time frame
- From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years
What was measured
Estimation of progression-free ratio defined as the duration of time from start of treatment to the time of progression divided by the duration of time from the last treatment received pre-trial to the time of progression on that treatment. The median progression-free ratio will be estimated with the range and a two-sided Wilcoxon Signed Rank test will be calculated to see if the progression free survival ratio is different from 1.0. This trial is powered to detect differences in the progression-free ratio for those with actionable mutations identified by NGS results and then treated with a targeted therapy. A hypothesized PFS ratio larger than 1.3 would suggest that the targeted therapy is doing better than the previous treatment received (not targeted), and we assume a null hypothesis PFS ratio of 1.0 (no difference).
Analysis population: For various reasons, 27 patients were not evaluable for the primary outcome. Five patients had no prior treatment but did have an actionable mutation to qualify them for inclusion in the study. Another ten patients were enrolled but never started treatment under this protocol. Nine patients started treatment but died prior to testing for best response and for progression. Two patients died with stable disease and one patient is alive with stable disease and no sign of progression .
Groups in this outcome
Drug Administration Based on Next Gen Sequencing Report
Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
| Group | Source count |
|---|---|
| Drug Administration Based on Next Gen Sequencing Report | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Drug Administration Based on Next Gen Sequencing Report | 0.73 | Not reported | 0.26 | 6.67 | Not reported |
Source statistical analyses
- group Description
- H0: Progression-free ratio = 1
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.966
- statistical Method
- Wilcoxon signed rank (2 sided)
Complete source fields
- analyses
- group Description
- H0: Progression-free ratio = 1
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.966
- statistical Method
- Wilcoxon signed rank (2 sided)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.26
- upper Limit
- 6.67
- value
- 0.73
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- Estimation of progression-free ratio defined as the duration of time from start of treatment to the time of progression divided by the duration of time from the last treatment received pre-trial to the time of progression on that treatment. The median progression-free ratio will be estimated with the range and a two-sided Wilcoxon Signed Rank test will be calculated to see if the progression free survival ratio is different from 1.0. This trial is powered to detect differences in the progression-free ratio for those with actionable mutations identified by NGS results and then treated with a targeted therapy. A hypothesized PFS ratio larger than 1.3 would suggest that the targeted therapy is doing better than the previous treatment received (not targeted), and we assume a null hypothesis PFS ratio of 1.0 (no difference).
- dispersion Type
- Full Range
- groups
- description
- Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
- id
- OG000
- title
- Drug Administration Based on Next Gen Sequencing Report
- param Type
- MEDIAN
- population Description
- For various reasons, 27 patients were not evaluable for the primary outcome. Five patients had no prior treatment but did have an actionable mutation to qualify them for inclusion in the study. Another ten patients were enrolled but never started treatment under this protocol. Nine patients started treatment but died prior to testing for best response and for progression. Two patients died with stable disease and one patient is alive with stable disease and no sign of progression .
- reporting Status
- POSTED
- time Frame
- From the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years
- title
- Progression Free Survival Ratio
- type
- PRIMARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice