Trial · NCT01255137
Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer
NCT01255137, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer. Trials, record NCT01255137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01255137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer
- NCT number
- NCT01255137
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adrenal Cortex Neoplasms
- Interventions
- Axitinib
- First posted
- 2010-12-07
- Last updated
- 2013-06-27
- Results first posted
- 2013-06-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | 2 years | Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study. |
| Secondary | Number of Participants With Adverse Events | 3/2/11 - 8/2/12 | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module. |
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 | Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | 2 years | Participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 3/2/11 - 8/2/12 | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | Adrenal Cortex Neoplasms | Complete Response | 0 | Participants | |
| Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | Adrenal Cortex Neoplasms | Partial Response | 0 | Participants | |
| Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | Adrenal Cortex Neoplasms | Progression | 13 | Participants | |
| Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC) | Adrenal Cortex Neoplasms | Stable Disease | 0 | Participants | |
| Number of Participants With Adverse Events | Adrenal Cortex Neoplasms | 13 | Participants |
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 | Adrenal Cortex Neoplasms | 13 | |
| Overall Study | COMPLETED | Adrenal Cortex Neoplasms | 13 | |
| Overall Study | NOT COMPLETED | Adrenal Cortex Neoplasms | 0 |
Source ClinicalTrials.gov
Adverse events91
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 | Adrenal Cortex Neoplasms | 6 | 13 | 10 |
| other | Activated partial thromboplastin time prolonged | Investigations | Adrenal Cortex Neoplasms | 2 | 13 | 2 |
| other | Alanine aminotransferase increased | Investigations | Adrenal Cortex Neoplasms | 4 | 13 | 5 |
| other | Alkaline phosphatase increased | Investigations | Adrenal Cortex Neoplasms | 5 | 13 | 8 |
| other | Anal hemorrhage | Gastrointestinal disorders | Adrenal Cortex Neoplasms | 1 | 13 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Adrenal Cortex Neoplasms | 8 | 13 | 14 |
| other | Anorexia | Metabolism and nutrition disorders | Adrenal Cortex Neoplasms | 4 | 13 | 10 |
| other | Anxiety | Psychiatric disorders | Adrenal Cortex Neoplasms | 1 | 13 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Adrenal Cortex Neoplasms | 5 | 13 | 8 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Adrenal Cortex Neoplasms | 1 | 13 | 1 |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adrenal Cortex Neoplasms | ||
| Total, other adverse events | Adrenal Cortex Neoplasms | 13 | 13 |
| Total, serious adverse events | Adrenal Cortex Neoplasms | 2 | 13 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT01255137
GET https://conductscience.org/api/trials/v1/NCT01255137/events?page=2