Trial · NCT00582400
A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver
NCT00582400, Phase 2, Terminated, The University of Texas Medical Branch, Galveston; results first posted 2016-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver. Trials, record NCT00582400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00582400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver
- NCT number
- NCT00582400
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Carcinoma, Hepatocellular
- Interventions
- arsenic trioxide
- First posted
- 2007-12-28
- Last updated
- 2016-02-19
- Results first posted
- 2016-02-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Related Toxicity. | 6 years | |
| Primary | Number of Patients With Response to Treatment (RECIST Criteria) | 6 years | Response included complete response, partial response or stable disease. |
| Secondary | Duration of Response. | 6 years | Time to progression. |
| Secondary | Progression Free Survival | 6 years | Time to progression from start of treatment |
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 | Number of Participants With Treatment Related Toxicity. | 6 years | participants | NUMBER | |
| PRIMARY | Number of Patients With Response to Treatment (RECIST Criteria) | 6 years | Participants who were evaluable for response | participants | NUMBER |
| SECONDARY | Duration of Response. | 6 years | Participants with response | months | MEDIAN |
| SECONDARY | Progression Free Survival | 6 years | 1 evaluable participant lost to follow up. No data collected. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Related Toxicity. | Arsenic Trioxide | 0 | participants | ||
| Number of Patients With Response to Treatment (RECIST Criteria) | Arsenic Trioxide | 1 | participants | ||
| Duration of Response. | Arsenic Trioxide | 8 | Full Range 8 to 8 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arsenic Trioxide | 9 | |
| Overall Study | COMPLETED | Arsenic Trioxide | 6 | |
| Overall Study | NOT COMPLETED | Arsenic Trioxide | 3 |
Source ClinicalTrials.gov
Adverse events7
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 | abdominal pain | Gastrointestinal disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
| other | abdominal edema | Gastrointestinal disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
| other | bilateral lower extremity weakness | Musculoskeletal and connective tissue disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
| other | dyspnea | Respiratory, thoracic and mediastinal disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
| serious | hemorrhagic diarrhea | Gastrointestinal disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
| serious | abdominal pain | Gastrointestinal disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | |
| serious | bilateral extremity edema | Musculoskeletal and connective tissue disorders | Arsenic Trioxide (Trisenox) | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arsenic Trioxide (Trisenox) | ||
| Total, other adverse events | Arsenic Trioxide (Trisenox) | 2 | 9 |
| Total, serious adverse events | Arsenic Trioxide (Trisenox) | 2 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00582400
GET https://conductscience.org/api/trials/v1/NCT00582400/registered