Trial · NCT02316340
Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer
NCT02316340, Phase 2, Completed, The University of Texas Health Science Center at San Antonio; results first posted 2024-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer. Trials, record NCT02316340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02316340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Colorectal Cancer
- NCT number
- NCT02316340
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Colorectal Cancer
- Interventions
- Vorinostat, Hydroxychloroquine, Regorafenib
- First posted
- 2014-12-12
- Last updated
- 2024-01-05
- Results first posted
- 2024-01-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib | Baseline to 12 months | CT Scan performed every 8 weeks to monitor progression for one year. |
| Secondary | Median Overall Survival (mOS) | Baseline up to 22 months | Overall survival was measured in months from baseline |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib | Baseline to 12 months | Primary endpoint: median progression-free survival (mPFS) at interim analysis after at least cycle one was completed. | months | MEDIAN |
| SECONDARY | Median Overall Survival (mOS) | Baseline up to 22 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib | Study Arm - VOR With HCQ | 1.9 | 95% Confidence Interval 1.87 to 4.35 | months | |
| Efficacy Based on Progression Free Survival of Vorinostat and Hydroxychloroquine Compared to Regorafenib | Control Arm - Regorafenib | 4.35 | 95% Confidence Interval 1.6 to NA | months | |
| Median Overall Survival (mOS) | Study Arm - VOR With HCQ | 6.77 | 95% Confidence Interval 4.0 to NA | Months | |
| Median Overall Survival (mOS) | Control Arm - Regorafenib | 7.23 | 95% Confidence Interval 4.8 to 10.8 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Progression | STARTED | Study Arm - VOR With HCQ | 20 | |
| First Progression | STARTED | Control Arm - Regorafenib | 22 | |
| First Progression | COMPLETED | Study Arm - VOR With HCQ | 17 | |
| First Progression | COMPLETED | Control Arm - Regorafenib | 21 | |
| First Progression | NOT COMPLETED | Study Arm - VOR With HCQ | 3 | |
| First Progression | NOT COMPLETED | Control Arm - Regorafenib | 1 | |
| Optional Cross-over (MD Discretion) | STARTED | Study Arm - VOR With HCQ | 5 | |
| Optional Cross-over (MD Discretion) | STARTED | Control Arm - Regorafenib | 13 | |
| Optional Cross-over (MD Discretion) | COMPLETED | Study Arm - VOR With HCQ | 2 | |
| Optional Cross-over (MD Discretion) | COMPLETED | Control Arm - Regorafenib | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
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 | Study Arm - VOR With HCQ | 1 | 20 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Control Arm - Regorafenib | 0 | 22 | 0 |
| other | Bilirubin increased | Blood and lymphatic system disorders | Study Arm - VOR With HCQ | 0 | 20 | 0 |
| other | Bilirubin increased | Blood and lymphatic system disorders | Control Arm - Regorafenib | 1 | 22 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Study Arm - VOR With HCQ | 2 | 20 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Control Arm - Regorafenib | 0 | 22 | 0 |
| other | Elevated transaminases | Hepatobiliary disorders | Study Arm - VOR With HCQ | 0 | 20 | 0 |
| other | Elevated transaminases | Hepatobiliary disorders | Control Arm - Regorafenib | 2 | 22 | 2 |
| other | Hand Foot Syndrome | Skin and subcutaneous tissue disorders | Study Arm - VOR With HCQ | 0 | 20 | 0 |
| other | Hand Foot Syndrome | Skin and subcutaneous tissue disorders | Control Arm - Regorafenib | 2 | 22 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Arm - VOR With HCQ | 20 | 20 |
| Total, all-cause mortality | Control Arm - Regorafenib | 22 | 22 |
| Total, other adverse events | Study Arm - VOR With HCQ | 7 | 20 |
| Total, other adverse events | Control Arm - Regorafenib | 8 | 22 |
| Total, serious adverse events | Study Arm - VOR With HCQ | 0 | 20 |
| Total, serious adverse events | Control Arm - Regorafenib | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35739299 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Study Arm - VOR With HCQ vs Control Arm - Regorafenib: deaths from any cause | Trial comparisons |
| Study Arm - VOR With HCQ vs Control Arm - Regorafenib: serious adverse events | Trial comparisons |
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/NCT02316340
GET https://conductscience.org/api/trials/v1/NCT02316340/registered