Trial · NCT02259725
Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors
NCT02259725, Phase 2, Completed, University of Southern California; results first posted 2021-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors. Trials, record NCT02259725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02259725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Treating Patients With Advanced or Metastatic Neuroendocrine Tumors
- NCT number
- NCT02259725
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
Gastrinoma, Glucagonoma, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Pancreatic Polypeptide Tumor, Pulmonary Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Somatostatinoma
- Interventions
- regorafenib, laboratory biomarker analysis
- First posted
- 2014-10-08
- Last updated
- 2021-12-15
- Results first posted
- 2021-12-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS | Time from start of treatment to time of progression or death on study whichever comes first, assessed at 6 months | Two parallel Simon's 2-stage phase II trials will be conducted to evaluate the efficacy of regorafenib in patients with advanced carcinoid (cohort A) or pancreatic islet cell tumors (cohort B). Will be summarized as a proportion of patients who are alive and progression-free among all patients in the primary data analysis set. The 95% confidence intervals (CIs) will be calculated using the Wilson method. Will be analyzed using Kaplan-Meier (KM) curves. The median PFS and 95% CIs will be calculated. The probability of 6-month PFS will be estimated from the KM curve too. |
| Secondary | Tumor Response Rate, Evaluated Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee | Up to 4 years | Will be calculated as a proportion of patients who have either a complete or partial response among all patients in the primary data analysis set. The 95% CIs will be given. |
| Secondary | Overall Survival | From start of treatment until death due to any cause, assessed up to 4 years | The 95% CIs will be calculated using the Wilson method. Will be analyzed using KM curves. |
| Secondary | Incidence of Adverse Events, Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Up to 4 years | Toxicity profile will be summarized by attribution: regorafenib-related and all reported, course: course 1 and all courses, type, and grade: grade 1-2, 3-4, and 5. |
| Other | Biomarkers Such as Messenger Ribonucleic Acid (mRNA) Levels or Germline Variations of Genes Related to Angiogenesis | Up to 4 years | The associations between biomarkers and clinical outcomes (6-month PFS, response, PFS, and overall survival) will be analyzed in univariate analysis first using appropriate methods. Multivariable analyses will be conducted to evaluate the independent effect of a marker on clinical outcome. All tests will be two-sided at a significance level of 0.05. P values will be adjusted for multiple comparisons. |
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 | PFS | Time from start of treatment to time of progression or death on study whichever comes first, assessed at 6 months | No analysis done. Only 3 subjects were enrolled out of accrual goal of 24 subjects. | ||
| SECONDARY | Tumor Response Rate, Evaluated Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee | Up to 4 years | No analysis was done. Only 3 subjects were enrolled out of accrual goal of 24 subjects. | ||
| SECONDARY | Overall Survival | From start of treatment until death due to any cause, assessed up to 4 years | Due to insufficient accrual (only 3 accrued), no analysis was performed. | ||
| SECONDARY | Incidence of Adverse Events, Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Up to 4 years | Data not collected | ||
| OTHER_PRE_SPECIFIED | Biomarkers Such as Messenger Ribonucleic Acid (mRNA) Levels or Germline Variations of Genes Related to Angiogenesis | Up to 4 years | Analysis not done. Only 3 subjects were enrolled out of the accrual goal of subjects. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Regorafenib) | 3 | |
| Overall Study | COMPLETED | Treatment (Regorafenib) | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Regorafenib) | 0 |
Source ClinicalTrials.gov
Adverse events34
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 | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Bloating | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Regorafenib) | 3 | 3 | 3 |
| other | Stomach pain | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Edema limbs | General disorders | Treatment (Regorafenib) | 1 | 3 | 1 |
| other | Fatigue | General disorders | Treatment (Regorafenib) | 1 | 3 | 3 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Regorafenib) | 0 | 3 |
| Total, other adverse events | Treatment (Regorafenib) | 3 | 3 |
| Total, serious adverse events | Treatment (Regorafenib) | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA014089 | University of Southern California Norris Comprehensive Cancer Center Support Grant (CCSG) | LERMAN, CARYN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT02259725
GET https://conductscience.org/api/trials/v1/NCT02259725/events?page=2