Trial · NCT03034200
Phase 2 Study of ONC201 in Neuroendocrine Tumors
NCT03034200, Phase 2, Completed, Peter Anderson; results first posted 2024-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of ONC201 in Neuroendocrine Tumors. Trials, record NCT03034200. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03034200
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of ONC201 in Neuroendocrine Tumors
- NCT number
- NCT03034200
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Peter Anderson
- Conditions
- Recurrent Neuroendocrine Tumor, Metastatic Neuroendocrine Tumor
- Interventions
- ONC201
- First posted
- 2017-01-27
- Last updated
- 2024-11-26
- Results first posted
- 2024-11-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response According to RECIST Criteria | Up to 1 Year | Complete Response (CR) Disappearance or fibrosis of all target lesions. Any pathologic lymph nodes must have reduction in short axis to \<10mm and standardized uptake value (SUV) is \<4. Partial Response (PR) At least 30% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) and any decrease in SUV in Fludeoxyglucose 18F (18FDG) imaging Stable disease (SD) 0-29% decrease in sum of longest diameters of target lesions (compared to initial on study baseline) or 0-19% increase in sum of longest diameters of target lesions (compared to initial on study baseline). SUV may increase or decrease Progressive disease 20% or more increase of sum of longest diameters of target lesions (compared to initial on study baseline). The sum must also be at an increase of at least 5mm or one or more new lesions that are considered metastatic disease |
| Secondary | Median Duration of Therapy | Up to 5 years | The median Duration of therapy was measured. Participants with stable disease + PR allowed to continue; participants with progression were taken off therapy. |
| Secondary | Overall Survival | Up to 1 Year | Time from beginning of treatment until death, or one year, whichever comes first. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response According to RECIST Criteria | Up to 1 Year | All participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Duration of Therapy | Up to 5 years | All participants were analyzed for this outcome measure. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 1 Year | All participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Participants With Decline in Karnofsky Performance Status | 3 months | All participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response According to RECIST Criteria | Arm A: Metastatic PC-PG | Complete Response (CR) | 0 | Participants | |
| Tumor Response According to RECIST Criteria | Arm B: Other NETs | Complete Response (CR) | 0 | Participants | |
| Tumor Response According to RECIST Criteria | Arm C: PC-PG + Other NETs | Complete Response (CR) | 0 | Participants | |
| Tumor Response According to RECIST Criteria | Arm A: Metastatic PC-PG | Partial Response (PR) | 5 | Participants | |
| Tumor Response According to RECIST Criteria | Arm B: Other NETs | Partial Response (PR) | 1 | Participants | |
| Tumor Response According to RECIST Criteria | Arm C: PC-PG + Other NETs | Partial Response (PR) | 1 | Participants | |
| Tumor Response According to RECIST Criteria | Arm A: Metastatic PC-PG | Stable Disease (SD) | 2 | Participants | |
| Tumor Response According to RECIST Criteria | Arm B: Other NETs | Stable Disease (SD) | 2 | Participants | |
| Tumor Response According to RECIST Criteria | Arm C: PC-PG + Other NETs | Stable Disease (SD) | 7 | Participants | |
| Tumor Response According to RECIST Criteria | Arm A: Metastatic PC-PG | Progressive disease | 3 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Metastatic PC-PG | 10 | |
| Overall Study | STARTED | Arm B: Other NETs | 12 | |
| Overall Study | STARTED | Arm C: PC-PG + Other NETs | 8 | |
| Overall Study | COMPLETED | Arm A: Metastatic PC-PG | 0 | |
| Overall Study | COMPLETED | Arm B: Other NETs | 1 | |
| Overall Study | COMPLETED | Arm C: PC-PG + Other NETs | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Metastatic PC-PG | 10 | |
| Overall Study | NOT COMPLETED | Arm B: Other NETs | 11 | |
| Overall Study | NOT COMPLETED | Arm C: PC-PG + Other NETs | 8 |
Source ClinicalTrials.gov
Adverse events405
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 | Spasticity | Nervous system disorders | Arm A: Metastatic PC-PG | 0 | 10 | |
| other | Spasticity | Nervous system disorders | Arm B: Other NETs | 0 | 12 | |
| other | Spasticity | Nervous system disorders | Arm C: PC-PG + Other NETs | 1 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A: Metastatic PC-PG | 0 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B: Other NETs | 0 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm C: PC-PG + Other NETs | 2 | 8 | |
| other | Alanine aminotransferase increased | Investigations | Arm A: Metastatic PC-PG | 0 | 10 | |
| other | Alanine aminotransferase increased | Investigations | Arm B: Other NETs | 0 | 12 | |
| other | Alanine aminotransferase increased | Investigations | Arm C: PC-PG + Other NETs | 1 | 8 | |
| other | Alkaline phosphatase increased | Investigations | Arm A: Metastatic PC-PG | 1 | 10 |
1 to 10 of 405Source ClinicalTrials.gov
See all 405 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Metastatic PC-PG | 6 | 10 |
| Total, all-cause mortality | Arm B: Other NETs | 8 | 12 |
| Total, all-cause mortality | Arm C: PC-PG + Other NETs | 2 | 8 |
| Total, other adverse events | Arm A: Metastatic PC-PG | 4 | 10 |
| Total, other adverse events | Arm B: Other NETs | 1 | 12 |
| Total, other adverse events | Arm C: PC-PG + Other NETs | 8 | 8 |
| Total, serious adverse events | Arm A: Metastatic PC-PG | 3 | 10 |
| Total, serious adverse events | Arm B: Other NETs | 1 | 12 |
| Total, serious adverse events | Arm C: PC-PG + Other NETs | 4 | 8 |
Source ClinicalTrials.gov
Papers8
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 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/NCT03034200
GET https://conductscience.org/api/trials/v1/NCT03034200/results?page=2