Trial · NCT00778817
IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
NCT00778817, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2013-11-06
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery. Trials, record NCT00778817. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00778817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery
- NCT number
- NCT00778817
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Adrenocortical Carcinoma, Stage III Adrenocortical Carcinoma, Stage IV Adrenocortical Carcinoma
- Interventions
- IMC-A12, mitotane
- First posted
- 2008-10-23
- Last updated
- 2014-04-29
- Results first posted
- 2013-11-06
- Limitations and caveats
- After the treatment of 20 subjects, a protocol defined interim analysis was completed for safety and futility. The trial was permanently halted based on futility concerns.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival Rate at 6 Weeks | 6 weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Progression-free Survival Rate at 12 Weeks | 12 weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Primary | Progression-free Survival Rate at 18 Weeks | 18 weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Best Response Rates | Up to 6 months | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
| Secondary | Response at 6 Weeks | 6 weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
| Secondary | Response at 12 Weeks | 12 weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
| Secondary | Response at 18 Weeks | 18 weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
| Secondary | Response at 48 Weeks | 48 weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks | 6 weeks | Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount). |
| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks | 12 weeks | Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival Rate at 6 Weeks | 6 weeks | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival Rate at 12 Weeks | 12 weeks | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | percentage of participants | NUMBER |
| PRIMARY | Progression-free Survival Rate at 18 Weeks | 18 weeks | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | percentage of participants | NUMBER |
| SECONDARY | Best Response Rates | Up to 6 months | percentage of participants | NUMBER | |
| SECONDARY | Response at 6 Weeks | 6 weeks | percentage of participants | NUMBER | |
| SECONDARY | Response at 12 Weeks | 12 weeks | percentage of participants | NUMBER | |
| SECONDARY | Response at 18 Weeks | 18 weeks | percentage of participants | NUMBER | |
| SECONDARY | Response at 48 Weeks | 48 weeks | percentage of participants | NUMBER | |
| SECONDARY | Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks | 6 weeks | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | participants | NUMBER |
| SECONDARY | Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks | 12 weeks | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival Rate at 6 Weeks | Chemotherapy and Monoclonal Antibody Therapy | 50 | percentage of participants | ||
| Progression-free Survival Rate at 12 Weeks | Chemotherapy and Monoclonal Antibody Therapy | 25 | percentage of participants | ||
| Progression-free Survival Rate at 18 Weeks | Chemotherapy and Monoclonal Antibody Therapy | 16.7 | percentage of participants | ||
| Best Response Rates | Chemotherapy and Monoclonal Antibody Therapy | Progressive disease (PD) | 45 | percentage of participants | |
| Best Response Rates | Chemotherapy and Monoclonal Antibody Therapy | Stable disease (SD) | 40 | percentage of participants | |
| Best Response Rates | Chemotherapy and Monoclonal Antibody Therapy | Partial response (PR) | 5 | percentage of participants | |
| Best Response Rates | Chemotherapy and Monoclonal Antibody Therapy | Complete response (CR) | 0 | percentage of participants | |
| Best Response Rates | Chemotherapy and Monoclonal Antibody Therapy | Unknown response | 10 | percentage of participants | |
| Response at 6 Weeks | Chemotherapy and Monoclonal Antibody Therapy | Progressive disease (PD) | 45 | percentage of participants | |
| Response at 6 Weeks | Chemotherapy and Monoclonal Antibody Therapy | Stable disease (SD) | 45 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy and Monoclonal Antibody Therapy | 20 | |
| Overall Study | COMPLETED | Chemotherapy and Monoclonal Antibody Therapy | 16 | |
| Overall Study | NOT COMPLETED | Chemotherapy and Monoclonal Antibody Therapy | 4 |
Source ClinicalTrials.gov
Adverse events25
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 | Dehydration | Metabolism and nutrition disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| other | Fatigue | General disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | Chemotherapy and Monoclonal Antibody Therapy | 2 | 20 | |
| serious | Abdominal pain | Gastrointestinal disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Alanine aminotransferase increased | Investigations | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Anorexia | Metabolism and nutrition disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Cholesterol high | Investigations | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Cognitive disturbance | Nervous system disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Confusion | Psychiatric disorders | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 | |
| serious | Creatinine increased | Investigations | Chemotherapy and Monoclonal Antibody Therapy | 1 | 20 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy and Monoclonal Antibody Therapy | ||
| Total, other adverse events | Chemotherapy and Monoclonal Antibody Therapy | 4 | 20 |
| Total, serious adverse events | Chemotherapy and Monoclonal Antibody Therapy | 9 | 20 |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT00778817
GET https://conductscience.org/api/trials/v1/NCT00778817/results?page=2