TriangleNCT03375320 · OUTCOME
Progression-free Survival (PFS)
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
- 36 months
What was measured
Will be assessed per Response Evaluation Criteria in Solid Tumors 1.1 determined by retrospective independent central review. Will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. The stratification factors will be used for the analysis. The hazard ratio (HR) for PFS will be estimated using a stratified Cox proportional hazards model, and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm.
Groups in this outcome
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
| Group | Source count |
|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 134 |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 69 |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 64 |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 8.4 | Not reported | 7.6 | 12.7 | Not reported |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 3.9 | Not reported | 3.0 | 5.7 | Not reported |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 13.8 | Not reported | 9.2 | 18.5 | Not reported |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 4.4 | Not reported | 3.0 | 5.9 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- One-sided unstratified log-rank
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- One-sided unstratified log-rank
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- One-sided unstratified log-rank
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- One-sided unstratified log-rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- 12.7
- value
- 8.4
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 5.7
- value
- 3.9
- group Id
- OG002
- lower Limit
- 9.2
- upper Limit
- 18.5
- value
- 13.8
- group Id
- OG003
- lower Limit
- 3.0
- upper Limit
- 5.9
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 69
- group Id
- OG002
- value
- 64
- group Id
- OG003
- value
- 31
- units
- Participants
- description
- Will be assessed per Response Evaluation Criteria in Solid Tumors 1.1 determined by retrospective independent central review. Will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. The stratification factors will be used for the analysis. The hazard ratio (HR) for PFS will be estimated using a stratified Cox proportional hazards model, and the 95% confidence interval (CI) for the HR will be provided. Results from an unstratified analysis will also be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG000
- title
- Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG001
- title
- Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
- description
- Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. \> \> Cabozantinib S-malate: Given PO \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG002
- title
- Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
- description
- Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression. \> \> Computed Tomography: Undergo CT \> \> Magnetic Resonance Imaging: Undergo MRI \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies \> \> X-Ray Imaging: Undergo x-ray
- id
- OG003
- title
- Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 36 months
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice