Trial · NCT01558661
Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
NCT01558661, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2017-11-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma. Trials, record NCT01558661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01558661
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
- NCT number
- NCT01558661
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- AG-013736 (AXITINIB)
- First posted
- 2012-03-20
- Last updated
- 2017-11-28
- Results first posted
- 2017-11-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 2 years | Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 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; Complete Response (CR), Disappearance of all target lesions |
| Secondary | Median Progression-free Survival (PFS). | 2 years | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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 | MYB Immunohistochemistry (IHC) | 2 years | |
| Secondary | Number of Participants With Next Generation Sequencing (NGS) | 2 years | Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded. |
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 | Overall Response Rate | 2 years | One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not for Progression Free Survival. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival (PFS). | 2 years | One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival. | months | MEDIAN |
| SECONDARY | MYB Immunohistochemistry (IHC) | 2 years | MYB immunohistochemistry (IHC) was carried out on tumors from 33 patients. MYB quantification was assessed as: 2+ for strong staining in \>50% of cancer cells, 1+ for weak or strong staining in \<50% of the cells and 0 for \<5% staining. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Next Generation Sequencing (NGS) | 2 years | One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | AG-013736 (AXITINIB) | Complete Response | 0 | Participants | |
| Overall Response Rate | AG-013736 (AXITINIB) | Partial Response | 3 | Participants | |
| Overall Response Rate | AG-013736 (AXITINIB) | Stable Disease | 25 | Participants | |
| Overall Response Rate | AG-013736 (AXITINIB) | Progressive Disease | 4 | Participants | |
| Overall Response Rate | AG-013736 (AXITINIB) | Non-evaluable | 1 | Participants | |
| Median Progression-free Survival (PFS). | AG-013736 (AXITINIB) | 5.7 | 95% Confidence Interval 5.3 to 9.1 | months | |
| MYB Immunohistochemistry (IHC) | AG-013736 (AXITINIB) | MYB IHC Testing Not Done | 7 | Participants | |
| MYB Immunohistochemistry (IHC) | AG-013736 (AXITINIB) | MYB IHC Score 0 | 13 | Participants | |
| MYB Immunohistochemistry (IHC) | AG-013736 (AXITINIB) | MYB IHC Score +1 | 8 | Participants | |
| MYB Immunohistochemistry (IHC) | AG-013736 (AXITINIB) | MYB IHC Score +2 | 5 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AG-013736 (AXITINIB) | 33 | |
| Overall Study | First Stage | AG-013736 (AXITINIB) | 18 | |
| Overall Study | Second Stage | AG-013736 (AXITINIB) | 15 | |
| Overall Study | COMPLETED | AG-013736 (AXITINIB) | 33 | |
| Overall Study | NOT COMPLETED | AG-013736 (AXITINIB) | 0 |
Source ClinicalTrials.gov
Adverse events77
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 | Hypertension | Vascular disorders | AG-013736 (AXITINIB) | 32 | 33 | |
| other | Fatigue | General disorders | AG-013736 (AXITINIB) | 30 | 33 | |
| other | Anorexia | Metabolism and nutrition disorders | AG-013736 (AXITINIB) | 18 | 33 | |
| other | Diarrhea | Gastrointestinal disorders | AG-013736 (AXITINIB) | 18 | 33 | |
| other | Hyperglycemia | Metabolism and nutrition disorders | AG-013736 (AXITINIB) | 18 | 33 | |
| other | Weight loss | Investigations | AG-013736 (AXITINIB) | 18 | 33 | |
| other | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | AG-013736 (AXITINIB) | 17 | 33 | |
| other | Nausea | Gastrointestinal disorders | AG-013736 (AXITINIB) | 16 | 33 | |
| other | Alanine aminotransferase increased | Investigations | AG-013736 (AXITINIB) | 15 | 33 | |
| other | Alkaline phosphatase increased | Investigations | AG-013736 (AXITINIB) | 14 | 33 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AG-013736 (AXITINIB) | 25 | 33 |
| Total, other adverse events | AG-013736 (AXITINIB) | 33 | 33 |
| Total, serious adverse events | AG-013736 (AXITINIB) | 10 | 33 |
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/NCT01558661
GET https://conductscience.org/api/trials/v1/NCT01558661/events?page=2