Trial · NCT03375320
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
NCT03375320, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors. Trials, record NCT03375320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03375320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
- NCT number
- NCT03375320
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 298 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm, Locally Advanced Digestive System Neuroendocrine Neoplasm, Locally Advanced Digestive System Neuroendocrine Tumor G1, Locally Advanced Lung Neuroendocrine Neoplasm, Locally Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm, Low Grade Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Tumor, Lung Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Lung Neuroendocrine Neoplasm, Metastatic Lung Neuroendocrine Tumor, Metastatic Pancreatic Neuroendocrine Neoplasm, Metastatic Pancreatic Neuroendocrine Tumor, Metastatic Thymus Neuroendocrine Neoplasm, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2, Non-Functioning Pancreatic Neuroendocrine Tumor, Pancreatic Serotonin-Producing Neuroendocrine Tumor, Thymus Neuroendocrine Tumor, Unresectable Digestive System Neuroendocrine Neoplasm, Unresectable Digestive System Neuroendocrine Tumor G1, Unresectable Lung Neuroendocrine Neoplasm, Unresectable Pancreatic Neuroendocrine Neoplasm, Unresectable Thymus Neuroendocrine Neoplasm
- Interventions
- Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Magnetic Resonance Imaging, Placebo Administration, Quality-of-Life Assessment, X-Ray Imaging
- First posted
- 2017-12-18
- Last updated
- 2026-10-26
- Results first posted
- 2024-10-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 36 months | 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. |
| Secondary | Overall Survival (OS) | 60 months | 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. |
| Secondary | 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) | 60 months | 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. |
| Secondary | Radiographic Response Rate | 36 months | 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 ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) | 36 months | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 60 months | months | MEDIAN | |
| SECONDARY | 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) | 60 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Radiographic Response Rate | 36 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 8.4 | 95% Confidence Interval 7.6 to 12.7 | months | |
| Progression-free Survival (PFS) | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 3.9 | 95% Confidence Interval 3.0 to 5.7 | months | |
| Progression-free Survival (PFS) | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 13.8 | 95% Confidence Interval 9.2 to 18.5 | months | |
| Progression-free Survival (PFS) | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 4.4 | 95% Confidence Interval 3.0 to 5.9 | months | |
| Overall Survival (OS) | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 21.9 | 95% Confidence Interval 18.8 to 30.4 | months | |
| Overall Survival (OS) | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 19.7 | 95% Confidence Interval 14.2 to 30.0 | months | |
| Overall Survival (OS) | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 40.0 | 95% Confidence Interval 31.3 to NA | months | |
| Overall Survival (OS) | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31.1 | 95% Confidence Interval 23.4 to NA | months | |
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) | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 104 | Participants | ||
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) | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 47 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 134 | |
| Overall Study | STARTED | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 69 | |
| Overall Study | STARTED | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 64 | |
| Overall Study | STARTED | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 | |
| Overall Study | Initiated Treatment | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 132 | |
| Overall Study | Initiated Treatment | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 67 | |
| Overall Study | Initiated Treatment | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 63 | |
| Overall Study | Initiated Treatment | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 | |
| Overall Study | COMPLETED | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 21 | |
| Overall Study | COMPLETED | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,740
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 1 | 134 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 0 | 69 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 1 | 64 | 9 |
| other | Abdominal distension | Gastrointestinal disorders | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 0 | 31 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 34 | 134 | 159 |
| other | Abdominal pain | Gastrointestinal disorders | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 22 | 69 | 48 |
| other | Abdominal pain | Gastrointestinal disorders | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 13 | 64 | 75 |
| other | Abdominal pain | Gastrointestinal disorders | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 3 | 31 | 14 |
| other | Acidosis | Metabolism and nutrition disorders | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 1 | 134 | 1 |
| other | Acidosis | Metabolism and nutrition disorders | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 0 | 69 | 0 |
1 to 10 of 1,740Source ClinicalTrials.gov
See all 1,740 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 60 | 134 |
| Total, all-cause mortality | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 37 | 69 |
| Total, all-cause mortality | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 21 | 64 |
| Total, all-cause mortality | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 11 | 31 |
| Total, other adverse events | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 134 | 134 |
| Total, other adverse events | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 69 | 69 |
| Total, other adverse events | Arm Ib (Cabozantinib S-malate, Pancreatic NET Cohort [pNET]) | 64 | 64 |
| Total, other adverse events | Arm IIb (Placebo, Pancreatic NET Cohort [pNET]) | 31 | 31 |
| Total, serious adverse events | Arm Ia (Cabozantinib S-malate, Extra-pancreatic NET Cohort [epNET]) | 89 | 134 |
| Total, serious adverse events | Arm IIa (Placebo, Extra-pancreatic NET Cohort [epNET]) | 41 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03375320
GET https://conductscience.org/api/trials/v1/NCT03375320/events?page=2