Trial · NCT05687123
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
NCT05687123, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors. Trials, record NCT05687123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05687123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
- NCT number
- NCT05687123
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Metastatic Pancreatic Neuroendocrine Tumor, Pancreatic Neoplasm, Stage III Pancreatic Neuroendocrine Tumor AJCC v8, Stage IV Pancreatic Neuroendocrine Tumor AJCC v8, Unresectable Pancreatic Neuroendocrine Tumor
- Interventions
- Biospecimen Collection, Computed Tomography, Lutetium Lu 177 Dotatate, Magnetic Resonance Imaging, Positron Emission Tomography, Sunitinib Malate
- First posted
- 2023-01-18
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Within the first cycle (8 weeks) | Dose-limiting toxicities (DLTs) during the first 8 weeks of the combination of sunitinib malate plus lutetium Lu 177 dotatate and incidence of treatment-emergent AEs during DLT observation period. DLTs will be defined as grade 3 or worse hematologic and non-hematologic toxicity that is considered clinically significant and at least possibly related to lutetium Lu 177 dotatate and sunitinib malate within the first cycle (8 weeks). Safety endpoints will be listed for each dose level and the tabulations of adverse events will also be produced by severity and by relationship to study drug |
| Secondary | Objective response (ORR) | Up to 4 weeks | ORR defined as the percentage of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. For efficacy data in the expansion cohort, ORR and its 95% confidence interval will be calculated. |
| Secondary | Duration of response | The time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST v1.1, assessed up to 4 weeks | The change over-time as well as the difference between sub-groups (i.e., toxicity by Common Terminology Criteria for Adverse Events \[CTCAE\], tumor response by RECIST 1.1, etc.) will be summarized using descriptive statistics and presented graphically. |
| Secondary | Progression-free survival (PFS) | The time from first dose to the earlier date of assessment of progression or death by any cause, assessed up to 4 weeks | The distribution of PFS will be described using Kaplan-Meier product limit methods. The change over-time as well as the difference between sub-groups (i.e., toxicity by CTCAE, tumor response by RECIST 1.1, etc.) will be summarized using descriptive statistics and presented graphically. |
| Secondary | Overall survival (OS) | From the date of first dose to the date of death by any cause, assessed up to 4 weeks | The distribution of OS will be described using Kaplan-Meier product limit methods. The change over-time as well as the difference between sub-groups (i.e., toxicity by CTCAE, tumor response by RECIST 1.1, etc.) will be summarized using descriptive statistics and presented graphically. |
| Secondary | Intensity of tumor uptake | Up to 4 weeks | Intensity of tumor uptake on pre-treatment somatostatin receptor (SSR) positron emission tomography (PET) and post-lutetium Lu 177, as well as the dosimetry imaging. The organ dosimetry will be summarized using descriptive statistics at each time point. The correlation between intensity of tumor uptake on pre-treatment SSR PET and post-lutetium Lu 177, as well as the dosimetry imaging will also be described using Spearman or Pearson correlation coefficient. |
| Secondary | Chromogranin A levels | Up to 4 weeks | Chromogranin A levels will be measured and chromogranin A responses will be defined as 50% or greater reduction from baseline or normalization per RADIANT-1 study. Chromogranin A levels and responses will be summarized using descriptive statistics. Responses will be correlated with radiographic responses using contingency tables. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 |
|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 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/NCT05687123
GET https://conductscience.org/api/trials/v1/NCT05687123/registered