Trial · NCT02678780
Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors
NCT02678780, Phase 2, Completed, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2025-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors. Trials, record NCT02678780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02678780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors
- NCT number
- NCT02678780
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Conditions
- Neuroendocrine Tumors
- Interventions
- Lenvatinib
- First posted
- 2016-02-10
- Last updated
- 2025-07-24
- Other registries' IDs
- eudract:2015-001467-39
- Results first posted
- 2025-07-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Up to 18 months | Data cut-off for the primary study analysis will happen following after the last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR. |
| Primary | Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment | Up to 18 months | Data cut-off for the primary study analysis will happen following after th e last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy |
| Secondary | Progression-free Survival (PFS) | Up to 18 months | Progression-free survival (PFS) is defined as the time from the date of treatment start (C1D1)to the date of first documentation of disease progression or death (whichever Occurs first) using RECIST 1.1. PFS censoring rules will follow FDA guidance in 2007 |
| Secondary | Number of Participants With Early Tumor Shrinkage (ETS) | Up to 18 months | To calculate early tumor shrinkage (ETS) rate, patients were classified as responders/non-responders after a period of 6 weeks (first post-baseline tumor assessment). Those who achieved a 20% reduction in target lesions after the first 6 weeks of treatment were classified as responders. |
| Secondary | Deepness of Response (DpR) | Up to 18 months | (DpR) defined as percentage of maximum tumor shrinkage observed at the nadir compared with baseline |
| Secondary | Tumour Shrinkage | 18 months | Number of patients that exhibited a deepness of response lower than 0%. |
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 | Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Up to 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment | Up to 18 months | percentage of participants with response | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) | Up to 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Early Tumor Shrinkage (ETS) | Up to 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Deepness of Response (DpR) | Up to 18 months | Percentage of tumour reduction | MEDIAN | |
| SECONDARY | Tumour Shrinkage | 18 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of the Pancreas | Best Overall Response CR | 0 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of Gastrointestinal Tract | Best Overall Response CR | 0 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of the Pancreas | Best Overall Response PR | 23 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of Gastrointestinal Tract | Best Overall Response PR | 9 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of the Pancreas | Best Overall Response SD | 27 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of Gastrointestinal Tract | Best Overall Response SD | 42 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of the Pancreas | Best Overall Response PD | 2 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of Gastrointestinal Tract | Best Overall Response PD | 1 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of the Pancreas | Not evaluable | 0 | Participants | |
| Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment | Neuroendocrine Tumors of Gastrointestinal Tract | Not evaluable | 3 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neuroendocrine Tumors of the Pancreas | 55 | |
| Overall Study | STARTED | Neuroendocrine Tumors of Gastrointestinal Tract | 56 | |
| Overall Study | COMPLETED | Neuroendocrine Tumors of the Pancreas | 28 | |
| Overall Study | COMPLETED | Neuroendocrine Tumors of Gastrointestinal Tract | 28 | |
| Overall Study | NOT COMPLETED | Neuroendocrine Tumors of the Pancreas | 27 | |
| Overall Study | NOT COMPLETED | Neuroendocrine Tumors of Gastrointestinal Tract | 28 |
Source ClinicalTrials.gov
Adverse events120
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 pain | Gastrointestinal disorders | Neuroendocrine Tumors of the Pancreas | 55 | 55 | 1,428 |
| other | Abdominal pain | Gastrointestinal disorders | Neuroendocrine Tumors of Gastrointestinal Tract | 56 | 56 | 1,220 |
| serious | Abdominal Pain | Gastrointestinal disorders | Neuroendocrine Tumors of the Pancreas | 3 | 55 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Neuroendocrine Tumors of Gastrointestinal Tract | 3 | 56 | |
| serious | Intestinal Obstruction | Gastrointestinal disorders | Neuroendocrine Tumors of the Pancreas | 3 | 55 | |
| serious | Intestinal Obstruction | Gastrointestinal disorders | Neuroendocrine Tumors of Gastrointestinal Tract | 3 | 56 | |
| serious | Acute Kidney Injury | Renal and urinary disorders | Neuroendocrine Tumors of the Pancreas | 2 | 55 | |
| serious | Acute Kidney Injury | Renal and urinary disorders | Neuroendocrine Tumors of Gastrointestinal Tract | 2 | 56 | |
| serious | Anal Abscess | Gastrointestinal disorders | Neuroendocrine Tumors of the Pancreas | 0 | 55 | |
| serious | Anal Abscess | Gastrointestinal disorders | Neuroendocrine Tumors of Gastrointestinal Tract | 2 | 56 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neuroendocrine Tumors of the Pancreas | 21 | 55 |
| Total, all-cause mortality | Neuroendocrine Tumors of Gastrointestinal Tract | 29 | 56 |
| Total, other adverse events | Neuroendocrine Tumors of the Pancreas | 55 | 55 |
| Total, other adverse events | Neuroendocrine Tumors of Gastrointestinal Tract | 56 | 56 |
| Total, serious adverse events | Neuroendocrine Tumors of the Pancreas | 23 | 55 |
| Total, serious adverse events | Neuroendocrine Tumors of Gastrointestinal Tract | 24 | 56 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Neuroendocrine Tumors of the Pancreas vs Neuroendocrine Tumors of Gastrointestinal Tract: deaths from any cause | Trial comparisons |
| Neuroendocrine Tumors of the Pancreas vs Neuroendocrine Tumors of Gastrointestinal Tract: 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/NCT02678780
GET https://conductscience.org/api/trials/v1/NCT02678780/results?page=2