Trial · NCT00848016
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
NCT00848016, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery. Trials, record NCT00848016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
- NCT number
- NCT00848016
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Adrenocortical Carcinoma, Stage III Adrenocortical Carcinoma, Stage IV Adrenocortical Carcinoma
- Interventions
- R-(-)-gossypol acetic acid
- First posted
- 2009-02-20
- Last updated
- 2014-05-07
- Results first posted
- 2014-02-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria | Up to 2 years | In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD. |
| Secondary | Overall Survival | From registration to date of last follow-up or death due to any cause, assessed up to 2 years | The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | From registration to progression or death, whichever occurs first, up to 2 years. | The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria | Up to 2 years | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | From registration to date of last follow-up or death due to any cause, assessed up to 2 years | months | MEDIAN | |
| SECONDARY | Progression-free Survival | From registration to progression or death, whichever occurs first, up to 2 years. | months | NUMBER |
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 |
|---|---|---|---|---|---|
The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria | Treatment (R-(-)-Gossypol Acetic Acid) | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Overall Survival | Treatment (R-(-)-Gossypol Acetic Acid) | 8.5 | 95% Confidence Interval 5.0 to 9.8 | months | |
| Progression-free Survival | Treatment (R-(-)-Gossypol Acetic Acid) | 1.9 | 95% Confidence Interval 1.8 to 2.0 | 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 | Treatment (R-(-)-Gossypol Acetic Acid) | 29 | |
| Overall Study | COMPLETED | Treatment (R-(-)-Gossypol Acetic Acid) | 29 | |
| Overall Study | NOT COMPLETED | Treatment (R-(-)-Gossypol Acetic Acid) | 0 |
Source ClinicalTrials.gov
Adverse events71
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 21 | 29 | 57 |
| other | Arrhythmia | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 1 |
| other | Atrial flutter | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 1 |
| other | Palpitations | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 1 |
| other | Sinus arrhythmia | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 3 | 29 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 14 | 29 | 20 |
| other | Constipation | Gastrointestinal disorders | Treatment (R-(-)-Gossypol Acetic Acid) | 1 | 29 | 2 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (R-(-)-Gossypol Acetic Acid) | ||
| Total, other adverse events | Treatment (R-(-)-Gossypol Acetic Acid) | 29 | 29 |
| Total, serious adverse events | Treatment (R-(-)-Gossypol Acetic Acid) | 11 | 29 |
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/NCT00848016
GET https://conductscience.org/api/trials/v1/NCT00848016/events?page=2