Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

secondary · POSTED

The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor \[NET\] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.

Source null

→

secondary · POSTED

For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.

Source null

→

secondary · POSTED

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.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Progression-free Survival (PFS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id: NCT03375320
qol key: qol-0000
source section id: NCT03375320-om-0000
source outcome index: 0
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Progression-free Survival (PFS)
measure definition: 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.
time frame: 36 months
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

PRO-CTCAE · Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id: NCT03375320
qol key: qol-0002
source section id: NCT03375320-om-0002
source outcome index: 2
instrument: PRO-CTCAE
instrument basis: matched 'pro-ctcae' in the study's own wording
scale title: Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
measure definition: For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.
time frame: 60 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Source null
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id: NCT03375320
trial label: Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 4
harms Count: 4
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0000
source section id
NCT03375320-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS)
endpoint definition
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.
time origin
36 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0001
source section id
NCT03375320-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
The analyses for OS will follow intent-to-treat (ITT) principle and will be conducted separately within each cohort (pancreatic neuroendocrine tumor \[NET\] and carcinoid tumor). The distribution of OS will be estimated using the method of Kaplan-Meier. The median OS, along with the 95% CI, will be estimated by the two treatment groups. Overall survival will be compared between treatment arms using the stratified log-rank test at a one-sided cumulative 2.5% level of significance. The stratified Cox regression will be used to estimate the HR of OS, along with the 95% CI. A hierarchical approach will be used to control for family-wise type-I error rate, therefore OS will be formally statistically tested only if the primary efficacy endpoint, PFS, is statistically significantly different between the two treatment groups.
time origin
60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0002
source section id
NCT03375320-om-0002
source outcome index
2
endpoint
Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
endpoint definition
For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.
time origin
60 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0003
source section id
NCT03375320-om-0003
source outcome index
3
endpoint
Radiographic Response Rate
endpoint definition
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.
time origin
36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0000
arm key
OG000
arm label
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
134
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0000
arm key
OG001
arm label
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0000
arm key
OG002
arm label
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0000
arm key
OG003
arm label
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0001
arm key
OG000
arm label
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
134
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0001
arm key
OG001
arm label
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0001
arm key
OG002
arm label
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0001
arm key
OG003
arm label
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0002
arm key
OG000
arm label
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
134
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0002
arm key
OG001
arm label
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
regimen
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
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0002
arm key
OG002
arm label
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
64
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
outcome key
om-0002
arm key
OG003
arm label
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
regimen
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
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03375320-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
harm key
EG000
source section id
NCT03375320-ae
event group key
EG000
event group label
Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET])
serious affected
89
serious at risk
134
other affected
134
other at risk
134
frequency threshold
0
collection period
60 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
harm key
EG001
source section id
NCT03375320-ae
event group key
EG001
event group label
Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET])
serious affected
41
serious at risk
69
other affected
69
other at risk
69
frequency threshold
0
collection period
60 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
harm key
EG002
source section id
NCT03375320-ae
event group key
EG002
event group label
Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET])
serious affected
49
serious at risk
64
other affected
64
other at risk
64
frequency threshold
0
collection period
60 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
harm key
EG003
source section id
NCT03375320-ae
event group key
EG003
event group label
Arm IIb (Placebo, Pancreatic NET Cohort [pNET])
serious affected
21
serious at risk
31
other affected
31
other at risk
31
frequency threshold
0
collection period
60 months
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
qol key
qol-0000
source section id
NCT03375320-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Progression-free Survival (PFS)
measure definition
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.
time frame
36 months
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-neuroendocrine-tumors-islet-cell-tumors
nct id
NCT03375320
qol key
qol-0002
source section id
NCT03375320-om-0002
source outcome index
2
instrument
PRO-CTCAE
instrument basis
matched 'pro-ctcae' in the study's own wording
scale title
Number of Patients Experiencing Grade 3+ Adverse Events (AEs) Graded According to the Common Terminology Criteria for Adverse Events (CTCAE) and Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
measure definition
For CTCAE data, the frequency tables will be reviewed to determine the patterns. The overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse). PRO-CTCAE data will, at minimum, be analyzed similarly to CTCAE data. The initial analysis of each PRO-CTCAE item will use all available scores in an analysis which mirrors the approach used for the CTCAE data. Supplemental analysis will use model-based multiple imputation incorporating baseline patient characteristics and physician-rated performance status. CTCAE data may be incorporated as auxiliary data into multiple imputation models for AEs which are captured by both PRO-CTCAE and CTCAE. Results from supplemental analysis will be descriptively compared to the results of the initial analysis to assess the robustness of results to missing data. Additional analyses of PRO-CTCAE data beyond those specified above may be undertaken.
time frame
60 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice