Trial · NCT01121939
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
NCT01121939, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2015-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers. Trials, record NCT01121939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
- NCT number
- NCT01121939
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- SCRI Development Innovations, LLC
- Conditions
- Neuroendocrine Carcinoma
- Interventions
- Bevacizumab, Pertuzumab, Sandostatin LAR® Depot
- First posted
- 2010-05-12
- Last updated
- 2016-02-05
- Results first posted
- 2015-09-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 18 months | The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Define Toxicity and Safety | 18 months | To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity |
| Secondary | Progression-Free Survival (PFS) | 18 months | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | 18 months | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
| Secondary | Disease Control Rate | 18 months | The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD. |
Source ClinicalTrials.gov
Outcomes5
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) | 18 months | Includes all patients | percentage of participants | NUMBER |
| SECONDARY | Define Toxicity and Safety | 18 months | All patients on study | participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | 18 months | Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment) | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 18 months | Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment) | months | MEDIAN |
| SECONDARY | Disease Control Rate | 18 months | Includes all patients | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Typical Carcinoid | 16 | percentage of participants | ||
| Objective Response Rate (ORR) | Pancreatic Islet Cell | 18 | percentage of participants | ||
| Objective Response Rate (ORR) | All Patients | 16 | percentage of participants | ||
| Define Toxicity and Safety | All Patients | Hypertension | 11 | participants | |
| Define Toxicity and Safety | All Patients | Pain | 5 | participants | |
| Define Toxicity and Safety | All Patients | Left ventricular systolic dysfunction | 5 | participants | |
| Define Toxicity and Safety | All Patients | Diarrhea | 3 | participants | |
| Define Toxicity and Safety | All Patients | Anemia | 1 | participants | |
| Define Toxicity and Safety | All Patients | Leukopenia | 1 | participants | |
| Progression-Free Survival (PFS) | Typical Carcinoid | 11.96 | 95% Confidence Interval 3.9 to 15.7 | months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients | 43 | |
| Overall Study | COMPLETED | All Patients | 0 | |
| Overall Study | NOT COMPLETED | All Patients | 43 |
Source ClinicalTrials.gov
Adverse events99
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 | Diarrhea | Gastrointestinal disorders | All Patients | 27 | 43 | |
| other | Fatigue | General disorders | All Patients | 27 | 43 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | All Patients | 18 | 43 | |
| other | Headache | Nervous system disorders | All Patients | 18 | 43 | |
| other | Hypertension | Vascular disorders | All Patients | 18 | 43 | |
| other | Nausea | Gastrointestinal disorders | All Patients | 17 | 43 | |
| other | Proteinuria | Renal and urinary disorders | All Patients | 16 | 43 | |
| other | Anemia | Blood and lymphatic system disorders | All Patients | 13 | 43 | |
| other | Vomiting | Gastrointestinal disorders | All Patients | 11 | 43 | |
| other | Dizziness | Nervous system disorders | All Patients | 10 | 43 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 42 | 43 |
| Total, serious adverse events | All Patients | 6 | 43 |
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 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/NCT01121939
GET https://conductscience.org/api/trials/v1/NCT01121939/events?page=2