TriangleNCT03375320 · OUTCOME
Radiographic Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 36 months
What was measured
Will be defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Radiographic response rate for both cohorts: the analyses for confirmed radiographic response rate will follow the ITT principle and will be conducted separately within each cohort (pancreatic NET and carcinoid tumor). The proportion of patients with either confirmed CR or confirmed PR as their best response will be estimated using point estimates and 95% confidence intervals. Radiographic response rate will be compared between treatment arms using the 2-sample z-test to compare sample proportion at a one-sided 2.5% level of significance.
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]) | 7 | Not reported | Not reported | Not reported | Not reported |
| Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 12 | Not reported | Not reported | Not reported | Not reported |
| Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.05
- statistical Method
- Chi-squared
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.01
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.05
- statistical Method
- Chi-squared
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.01
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 0
- 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 defined as the proportion of patients in each arm whose best response is either complete response (CR) or partial response (PR). Radiographic response rate for both cohorts: the analyses for confirmed radiographic response rate will follow the ITT principle and will be conducted separately within each cohort (pancreatic NET and carcinoid tumor). The proportion of patients with either confirmed CR or confirmed PR as their best response will be estimated using point estimates and 95% confidence intervals. Radiographic response rate will be compared between treatment arms using the 2-sample z-test to compare sample proportion at a one-sided 2.5% level of significance.
- 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 36 months
- title
- Radiographic Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice