Trial · NCT01280201
Pazopanib as Single Agent in Advanced NETs
NCT01280201, Phase 2, Completed, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2019-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pazopanib as Single Agent in Advanced NETs. Trials, record NCT01280201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01280201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pazopanib as Single Agent in Advanced NETs
- NCT number
- NCT01280201
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Conditions
- Advanced/Metastatic Neuroendocrine Tumors
- Interventions
- Pazopanib
- First posted
- 2011-01-20
- Last updated
- 2019-05-29
- Other registries' IDs
- eudract:2010-020749-28
- Results first posted
- 2019-03-04
- Limitations and caveats
Small sample size, heterogeneous location and degree of differentiation of primary tumors, and lack of an appropriate control group. Additionally,response was evaluated by the investigator and not by an independent committee.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate | 6 months | Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI: complete response (CR) considered as dissapereance of all target lesions: partial response (PR), considered as \>=30% decrease in the sum of the longest diameter of target lesions, or stable disease (SD) considered as a decrease \<30%, after pazopanib was started. Clinical benefit rate (CBR) was defined as the percentage of patients achieving CR, PR or SD. |
| Secondary | Number of Patients Who Had an Event (Disease Progression or Death) | 3 years | Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patietnts whose target lesions have been reported with a \>=30% increase in the sum of the longest diameter of target lesions. |
| Secondary | Radiological Objective Complete Response Rate | 3 years | Per Response Evaluation Criteria In Solid Tumor Criteria (RECIST v1.0) for target lesions and assessed by MRI, considered as the proportion of patients whose target lessions have dissaperead after treatment. |
| Secondary | Duration of Response (DoR) | 3 years | Defined, for the subset of patients with a confirmed CR o PR, as the time from first documented evidence of CR or PR until first documented disease progression or death due to any cause. The DR data will be censored the day after the last evaluation in those patients who did not present an objective tumoral progression and did not died during their participation in the trial. The DR will be assessed only in the subset of patients presenting objective response. |
| Secondary | Safety Assessment Criteria | 3 years | Security and tolerance to the study medication will be determined evaluating the type, incidence, severity, timing, seriousness and connections with the treatment of the reported adverse events, physical examinations and laboratory tests. Toxicity will be classified according to NCI-CTCAE v 4.0. |
| Secondary | Predictive Value of Baseline CTC (Count of 0) for Response to Treatma | 3 years | Predictive value of the differente biomarkers included in the study was evaluated using multivariate analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Had an Event (Disease Progression or Death) | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Radiological Objective Complete Response Rate | 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response (DoR) | 3 years | months | MEDIAN | |
| SECONDARY | Safety Assessment Criteria | 3 years | Number of participantes with grade 3 or 4 AEs | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Predictive Value of Baseline CTC (Count of 0) for Response to Treatma | 3 years | Odds ratio | NUMBER |
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 |
|---|---|---|---|---|---|
| Clinical Benefit Rate | Arm of Pazopanib | 11 | Participants | ||
| Number of Patients Who Had an Event (Disease Progression or Death) | Arm of Pazopanib | 35 | Participants | ||
| Radiological Objective Complete Response Rate | Arm of Pazopanib | 4 | Participants | ||
| Duration of Response (DoR) | Arm of Pazopanib | 11.3 | 95% Confidence Interval 2.0 to 20.6 | months | |
| Safety Assessment Criteria | Arm of Pazopanib | 28 | Participants | ||
| Predictive Value of Baseline CTC (Count of 0) for Response to Treatma | Arm of Pazopanib | 6.2 | 95% Confidence Interval 0.45 to 86.5 | Odds ratio |
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 | Arm of Pazopanib | 44 | |
| Overall Study | COMPLETED | Arm of Pazopanib | 44 | |
| Overall Study | NOT COMPLETED | Arm of Pazopanib | 0 |
Source ClinicalTrials.gov
Adverse events30
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 |
|---|---|---|---|---|---|---|
| serious | HEPATOTOXICITY | Hepatobiliary disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | DIABETIC DECOMPENSATION | Endocrine disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | INTESTINAL SUBOCLUSION | Gastrointestinal disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | HYPERGLUCEMIA | Metabolism and nutrition disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | GENERALIZED CRISIS | Psychiatric disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | OBSTRUCTIVE ICTERY | Hepatobiliary disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | OLIGOARTRALGIAS | Musculoskeletal and connective tissue disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | HYPERTENSIVE CRISIS | Vascular disorders | Arm of Pazopanib | 1 | 44 | 1 |
| serious | RESPIRATORY INFECTION BY E.COLI | Infections and infestations | Arm of Pazopanib | 1 | 44 | 1 |
| serious | ACTIVE TUBERCULOSIS | Infections and infestations | Arm of Pazopanib | 1 | 44 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm of Pazopanib | 1 | 44 |
| Total, other adverse events | Arm of Pazopanib | 0 | 44 |
| Total, serious adverse events | Arm of Pazopanib | 19 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26063633 | 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/NCT01280201
GET https://conductscience.org/api/trials/v1/NCT01280201/events?page=2