Trial · NCT01229943
Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery
NCT01229943, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery. Trials, record NCT01229943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery
- NCT number
- NCT01229943
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Pancreatic Neuroendocrine Tumor, Locally Advanced Pancreatic Neuroendocrine Tumor, Pancreatic Gastrinoma, Pancreatic Neuroendocrine Tumor G1, Pancreatic Neuroendocrine Tumor G2, Pancreatic Vipoma
- Interventions
- Bevacizumab, Everolimus, Octreotide Acetate
- First posted
- 2010-10-28
- Last updated
- 2022-08-04
- Results first posted
- 2016-02-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | From study entry to the date of documented progression or death from any cause, up to 3 years | Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions. |
| Secondary | Overall Response Rate | Up to 3 years | The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions. |
| Secondary | Overall Survival (OS) | From registration to time of death, assessed up to 3 years | Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method. |
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 | Progression Free Survival | From study entry to the date of documented progression or death from any cause, up to 3 years | months | MEDIAN | |
| SECONDARY | Overall Response Rate | Up to 3 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) | From registration to time of death, assessed up to 3 years | 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 |
|---|---|---|---|---|---|
| Progression Free Survival | Arm I (Octreotide Acetate and Everolimus) | 14.0 | 95% Confidence Interval 9.1 to 16.9 | months | |
| Progression Free Survival | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 16.7 | 95% Confidence Interval 12.6 to 19.7 | months | |
| Overall Response Rate | Arm I (Octreotide Acetate and Everolimus) | 12 | percentage of participants | ||
| Overall Response Rate | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 31 | percentage of participants | ||
| Overall Survival (OS) | Arm I (Octreotide Acetate and Everolimus) | 35.0 | 95% Confidence Interval 29.9 to NA | months | |
| Overall Survival (OS) | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 36.7 | 95% Confidence Interval 31.8 to NA | 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 | Arm I (Octreotide Acetate and Everolimus) | 75 | |
| Overall Study | STARTED | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 75 | |
| Overall Study | COMPLETED | Arm I (Octreotide Acetate and Everolimus) | 57 | |
| Overall Study | COMPLETED | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 58 | |
| Overall Study | NOT COMPLETED | Arm I (Octreotide Acetate and Everolimus) | 18 | |
| Overall Study | NOT COMPLETED | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 17 |
Source ClinicalTrials.gov
Adverse events870
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 | Anemia | Blood and lymphatic system disorders | Arm I (Octreotide Acetate and Everolimus) | 29 | 74 | 226 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 40 | 73 | 332 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm I (Octreotide Acetate and Everolimus) | 1 | 74 | 2 |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 4 | 73 | 6 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (Octreotide Acetate and Everolimus) | 0 | 74 | 0 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 1 | 73 | 3 |
| other | Hemolytic uremic syndrome | Blood and lymphatic system disorders | Arm I (Octreotide Acetate and Everolimus) | 0 | 74 | 0 |
| other | Hemolytic uremic syndrome | Blood and lymphatic system disorders | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 1 | 73 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Octreotide Acetate and Everolimus) | 1 | 74 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 1 | 73 | 2 |
1 to 10 of 870Source ClinicalTrials.gov
See all 870 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Octreotide Acetate and Everolimus) | ||
| Total, all-cause mortality | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | ||
| Total, other adverse events | Arm I (Octreotide Acetate and Everolimus) | 73 | 74 |
| Total, other adverse events | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 72 | 73 |
| Total, serious adverse events | Arm I (Octreotide Acetate and Everolimus) | 20 | 74 |
| Total, serious adverse events | Arm II (Octreotide Acetate, Everolimus, and Bevacizumab) | 31 | 73 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Octreotide Acetate and Everolimus) vs Arm II (Octreotide Acetate, Everolimus, and Bevacizumab): serious adverse events |
Source 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/NCT01229943
GET https://conductscience.org/api/trials/v1/NCT01229943/events?page=2