Trial · NCT03215264
To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer
NCT03215264, Phase 1, Completed, Abramson Cancer Center at Penn Medicine; results first posted 2023-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer. Trials, record NCT03215264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03215264
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer
- NCT number
- NCT03215264
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Conditions
- Colorectal Cancer
- Interventions
- hydroxychloroquine, entinostat, regorafenib
- First posted
- 2017-07-12
- Last updated
- 2023-11-09
- Results first posted
- 2023-11-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Hydroxychloroquine and Entinostat in Combination With Regorafenib | 18 months | Participants were evaluable for toxicity if they have taken one dose of HCQ and one dose of entinostat. To be considered for evaluability in a Phase I cohort in the absence of dose-limiting toxicity, patients should have completed \> 85% of HCQ doses, and at least 3 of 4 entinostat doses. The MTD will be defined as a) the dose producing DLT in 1 out of 6 patients, or b) the dose level below the dose which produced DLT in ≥ 2 out of 3 patients, or in ≥ 2 out of 6 patients. DLTs will be defined by toxicity occurring during the first 4 weeks of this study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Hydroxychloroquine and Entinostat in Combination With Regorafenib | 18 months | mg | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Hydroxychloroquine and Entinostat in Combination With Regorafenib | All Participants | Hydroxychloroquine Daily | 1200 | mg | |
| Maximum Tolerated Dose (MTD) of Hydroxychloroquine and Entinostat in Combination With Regorafenib | All Participants | Entinostat weekly | 5 | mg |
Source ClinicalTrials.gov
Participant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Level 1 | STARTED | Dose Level 1 | 6 | |
| Dose Level 1 | STARTED | Dose Level 2 | 0 | |
| Dose Level 1 | STARTED | Dose Level 3 | 0 | |
| Dose Level 1 | COMPLETED | Dose Level 1 | 6 | |
| Dose Level 1 | COMPLETED | Dose Level 2 | 0 | |
| Dose Level 1 | COMPLETED | Dose Level 3 | 0 | |
| Dose Level 1 | NOT COMPLETED | Dose Level 1 | 0 | |
| Dose Level 1 | NOT COMPLETED | Dose Level 2 | 0 | |
| Dose Level 1 | NOT COMPLETED | Dose Level 3 | 0 | |
| Dose Level 2 | STARTED | Dose Level 1 | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events156
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 | Dose Level 1 | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 2 | 3 | 7 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 3 | 3 | 7 | |
| other | Bloating | Gastrointestinal disorders | Dose Level 1 | 1 | 6 | |
| other | Bloating | Gastrointestinal disorders | Dose Level 2 | 1 | 7 | |
| other | Bloating | Gastrointestinal disorders | Dose Level 3 | 0 | 7 | |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Level 1 | 0 | 6 | |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Level 2 | 3 | 7 | |
| other | Abdominal Pain | Gastrointestinal disorders | Dose Level 3 | 0 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Dose Level 1 | 1 | 6 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 0 | 6 |
| Total, all-cause mortality | Dose Level 2 | 0 | 7 |
| Total, all-cause mortality | Dose Level 3 | 0 | 7 |
| Total, other adverse events | Dose Level 1 | 6 | 6 |
| Total, other adverse events | Dose Level 2 | 7 | 7 |
| Total, other adverse events | Dose Level 3 | 7 | 7 |
| Total, serious adverse events | Dose Level 1 | 1 | 6 |
| Total, serious adverse events | Dose Level 2 | 0 | 7 |
| Total, serious adverse events | Dose Level 3 | 6 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35552447 | DERIVED |
Source PubMed
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/NCT03215264
GET https://conductscience.org/api/trials/v1/NCT03215264/flow?page=2