Trial · NCT01466036
Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
NCT01466036, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2023-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors. Trials, record NCT01466036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01466036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
- NCT number
- NCT01466036
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
- Interventions
- Cabozantinib
- First posted
- 2011-11-07
- Last updated
- 2024-03-05
- Results first posted
- 2023-07-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Imaging was performed cycles 2,4,6 every 8 weeks for the first 24 weeks, then every 3rd cycle every 12 weeks until progression or EOT. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Cycle=28 days. | The objective response rate of cabozantinib was evaluated according to RECIST v 1.1 criteria (Response Evaluation Criteria In Solid Tumors v 1.1). Disease was assessed using CT and/or MRI scans. RECIST 1.1 criteria include the following categories of disease response: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = 30% or more decrease in the sum of the longest diameter of target lesions; Stable disease (SD) = less than 30% decrease but no more than 20% increase in sum of the longest diameter of target lesions. Objective response rate consisted of CR + PR. |
| Secondary | Progression Free Survival (PFS) | Restaging imaging was performed after cycles 2, 4, and 6 (every 8 weeks for the first 24 weeks), then every 3rd cycle (every 12 weeks) until disease progression or end of study treatment. Median follow-up is 89.1 months. Cycle = 28 days. | Progression-free survival was defined as time in months from initiation of treatment until disease progression by RECIST 1.1 criteria or death from any cause. Progressive disease by RECIST 1.1 criteria is defined as at least a 20% increase in the sum of the longest dimensions of target lesions, taking as reference the smallest sum of longest dimensions recorded since the treatment started; the appearance of one or more new lesions; unequivocal progression of existing non-target lesions. |
| Secondary | Overall Survival (OS) | Median follow-up time of 89.1 months. | Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Imaging was performed cycles 2,4,6 every 8 weeks for the first 24 weeks, then every 3rd cycle every 12 weeks until progression or EOT. Median treatment duration was 8 cycles for the Carcinoid cohort and 12.5 cycles for the PNET cohort. Cycle=28 days. | Response rate by RECIST 1.1 was calculated by including all patients who started study therapy. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | Restaging imaging was performed after cycles 2, 4, and 6 (every 8 weeks for the first 24 weeks), then every 3rd cycle (every 12 weeks) until disease progression or end of study treatment. Median follow-up is 89.1 months. Cycle = 28 days. | months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | Median follow-up time of 89.1 months. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Metastatic or Unresectable PNET | 3 | Participants | ||
| Objective Response Rate (ORR) | Metastatic or Unresectable Carcinoid | 7 | Participants | ||
| Progression Free Survival (PFS) | Metastatic or Unresectable PNET | 21.1 | 95% Confidence Interval 8.6 to 32.0 | months | |
| Progression Free Survival (PFS) | Metastatic or Unresectable Carcinoid | 17.6 | 95% Confidence Interval 8.3 to 23.8 | months | |
| Overall Survival (OS) | Metastatic or Unresectable PNET | 37.3 | 95% Confidence Interval 14.5 to 70.7 | months | |
| Overall Survival (OS) | Metastatic or Unresectable Carcinoid | 36.1 | 95% Confidence Interval 20.6 to 65.5 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metastatic or Unresectable PNET | 20 | |
| Overall Study | STARTED | Metastatic or Unresectable Carcinoid | 41 | |
| Overall Study | COMPLETED | Metastatic or Unresectable PNET | 0 | |
| Overall Study | COMPLETED | Metastatic or Unresectable Carcinoid | 0 | |
| Overall Study | NOT COMPLETED | Metastatic or Unresectable PNET | 20 | |
| Overall Study | NOT COMPLETED | Metastatic or Unresectable Carcinoid | 41 |
Source ClinicalTrials.gov
Adverse events376
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 | Metastatic or Unresectable PNET | 0 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Metastatic or Unresectable Carcinoid | 5 | 41 | |
| other | Abdominal pain | Gastrointestinal disorders | Metastatic or Unresectable PNET | 10 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Metastatic or Unresectable Carcinoid | 20 | 41 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Metastatic or Unresectable PNET | 1 | 20 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Metastatic or Unresectable Carcinoid | 3 | 41 | |
| other | Acute kidney injury | Renal and urinary disorders | Metastatic or Unresectable PNET | 1 | 20 | |
| other | Acute kidney injury | Renal and urinary disorders | Metastatic or Unresectable Carcinoid | 1 | 41 | |
| other | Akathisia | Nervous system disorders | Metastatic or Unresectable PNET | 0 | 20 | |
| other | Akathisia | Nervous system disorders | Metastatic or Unresectable Carcinoid | 2 | 41 |
1 to 10 of 376Source ClinicalTrials.gov
See all 376 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metastatic or Unresectable PNET | 1 | 20 |
| Total, all-cause mortality | Metastatic or Unresectable Carcinoid | 3 | 41 |
| Total, other adverse events | Metastatic or Unresectable PNET | 20 | 20 |
| Total, other adverse events | Metastatic or Unresectable Carcinoid | 41 | 41 |
| Total, serious adverse events | Metastatic or Unresectable PNET | 15 | 20 |
| Total, serious adverse events | Metastatic or Unresectable Carcinoid | 24 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metastatic or Unresectable PNET vs Metastatic or Unresectable Carcinoid: Objective Response Rate (ORR) | Trial comparisons |
| Metastatic or Unresectable PNET vs Metastatic or Unresectable Carcinoid: deaths from any cause | Trial comparisons |
| Metastatic or Unresectable PNET vs Metastatic or Unresectable Carcinoid: serious adverse events | Trial comparisons |
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/NCT01466036
GET https://conductscience.org/api/trials/v1/NCT01466036/events?page=2