Trial · NCT04750954
Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors
NCT04750954, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors. Trials, record NCT04750954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04750954
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors
- NCT number
- NCT04750954
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 29 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Neuroendocrine Neoplasm
- Interventions
- Biospecimen Collection, Computed Tomography, Lutetium Lu 177 Dotatate, Magnetic Resonance Imaging, Peposertib
- First posted
- 2021-02-11
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase 2 dose | Up to 8 weeks | |
| Primary | Dose limiting toxicity | Up to 24 months post-treatment | Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of toxicity for each adverse event category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. Will describe all serious (\>= grade 3) toxicity events on a patient-by-patient basis. Frequency and incidence tables of toxicity and adverse events will be generated in the overall patient group and by dose level depending on patient enrollment. |
| Secondary | Overall response rate | Up to 24 months post-treatment | Will be estimated along with 95% exact binomial confidence interval. |
| Secondary | Progression free survival | Up to 24 months post-treatment | Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated. |
| Secondary | Overall survival | Up to 24 months post-treatment | Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated. |
| Other | Radiographic expression of somatostatin receptors | Baseline up to 24 months post-treatment | Will be summarized using descriptive statistics and changes from baseline versus follow-up time points will be assessed using paired test methodologies. |
| Other | Pharmacokinetic (PK) analysis | Baseline, cycle 1 days 2, 4, 9, 15, and 22 | PK parameters will be estimated from patients enrolled in the dose escalation portion of the phase 1 trial. PK parameters will be compared with historical controls, and exploratorily, may correlate exposure to toxicity, and incorporate data into a population PK model. |
| Other | Krenning score from the gallium 68 or copper 64 dotatate | Up to 24 months post-treatment | Will be summarized by calculating the proportion of patients in each Krenning score category and exploratory assessments for association with clinical response will be performed using Fisher's exact test. Median, interquartile range will be calculated for quantitative image measurements from gallium 68 or copper 64 dotatate and exploratory comparison of levels with clinical response will be performed using two sample t-test or nonparametric analogs. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35205614 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| UM1CA186712 | The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network | CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH | OHIO STATE 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/NCT04750954
GET https://conductscience.org/api/trials/v1/NCT04750954/registered