Trial · NCT01253161
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
NCT01253161, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2022-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs). Trials, record NCT01253161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01253161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
- NCT number
- NCT01253161
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Neuroendocrine Tumors, Carcinoid Tumors
- Interventions
- Pasireotide Long Acting Release (LAR)
- First posted
- 2010-12-03
- Last updated
- 2023-03-06
- Results first posted
- 2022-01-18
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 (PFS) at One Year | 12 months | PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Overall Radiographic Response Rate (ORR) | Up to 48 months | Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. |
| Secondary | Adverse Events Possibly Related to Study Treatment | Up to 48 months | Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). |
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 (PFS) at One Year | 12 months | Evaluable participants | months | MEDIAN |
| SECONDARY | Overall Radiographic Response Rate (ORR) | Up to 48 months | evaluable participants | percentage of participants | NUMBER |
| SECONDARY | Adverse Events Possibly Related to Study Treatment | Up to 48 months | All participants who received at least one dose of study drug | events | NUMBER |
Source ClinicalTrials.gov
Results by group5
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) at One Year | Pasireotide LAR Treatment | 11 | 95% Confidence Interval 7.6 to 16 | months | |
| Overall Radiographic Response Rate (ORR) | Pasireotide LAR Treatment | Partial Response | 4 | percentage of participants | |
| Overall Radiographic Response Rate (ORR) | Pasireotide LAR Treatment | Stable Disease | 60 | percentage of participants | |
| Overall Radiographic Response Rate (ORR) | Pasireotide LAR Treatment | Progressive Disease | 36 | percentage of participants | |
| Adverse Events Possibly Related to Study Treatment | Pasireotide LAR Treatment | 42 | events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pasireotide LAR Treatment | 29 | |
| Overall Study | COMPLETED | Pasireotide LAR Treatment | 28 | |
| Overall Study | NOT COMPLETED | Pasireotide LAR Treatment | 1 |
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 | Hyperglycemia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 24 | 29 | 147 |
| other | Anorexia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 4 | 29 | 5 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 2 | 29 | 14 |
| other | Hyponatremia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 2 | 29 | 12 |
| other | Dehydration | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 1 | 29 | 1 |
| other | Glucose intolerance | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 1 | 29 | 1 |
| other | Hypercalcemia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 1 | 29 | 5 |
| other | Hypermagnesemia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 1 | 29 | 1 |
| other | Hypokalemia | Metabolism and nutrition disorders | Pasireotide LAR Treatment | 1 | 29 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Pasireotide LAR Treatment | 11 | 29 | 13 |
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 | Pasireotide LAR Treatment | 6 | 29 |
| Total, other adverse events | Pasireotide LAR Treatment | 28 | 29 |
| Total, serious adverse events | Pasireotide LAR Treatment | 12 | 29 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25376618 | DERIVED |
Source PubMed
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/NCT01253161
GET https://conductscience.org/api/trials/v1/NCT01253161/events?page=2