Trial · NCT01967576
Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma
NCT01967576, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-08-31
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 Pheochromocytoma/Paraganglioma. Trials, record NCT01967576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01967576
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 Pheochromocytoma/Paraganglioma
- NCT number
- NCT01967576
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Pheochromocytoma, Paraganglioma
- Interventions
- Axitinib (AG-013736)
- First posted
- 2013-10-23
- Last updated
- 2021-01-06
- Results first posted
- 2020-08-31
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response (Partial Response + Complete Response) | Patients were assessed every 12 weeks (+/- week) up to 40.6 months | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or no-target) must have reduction in short axis to \<10 mm. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD) is at least 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). |
| Secondary | Progression - Free Survival (PFS) | time from start of treatment to time of progression or death, up to 5 years and 9 months | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least 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 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Change in Vascular Endothelial Growth Factor Receptors (VEGFR) in Blood in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma | up to 3 years | The measurement of VEGFR in blood will be performed using a semi-quantitative immunohistochemistry assay. |
| Secondary | Pharmacogenomics Analyses | up to 3 years | Measuring genetic alterations. |
| Secondary | Change From Baseline in Plasma Levels of Axitinib | Baseline and 3 years | Pharmacokinetic analysis will be done to determine drug levels in blood. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 54 months and 29 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes6
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 Clinical Response (Partial Response + Complete Response) | Patients were assessed every 12 weeks (+/- week) up to 40.6 months | 2/14 participants were not evaluated for this outcome measure. Current Investigator inherited this trial when the original investigator left the National Institutes of Health (NIH). The reason participants were not evaluated is unknown. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression - Free Survival (PFS) | time from start of treatment to time of progression or death, up to 5 years and 9 months | months | MEDIAN | |
| SECONDARY | Change in Vascular Endothelial Growth Factor Receptors (VEGFR) in Blood in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma | up to 3 years | Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected. | ||
| SECONDARY | Pharmacogenomics Analyses | up to 3 years | Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected. | ||
| SECONDARY | Change From Baseline in Plasma Levels of Axitinib | Baseline and 3 years | Blood samples were collected on a subset of participants, but assays were never performed on any of the samples and therefore no data for the Outcome Measures were collected. | ||
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 54 months and 29 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
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 Clinical Response (Partial Response + Complete Response) | 1/Arm 1-Axitinib | Confirmed Partial Response | 5 | Participants | |
| Number of Participants With Clinical Response (Partial Response + Complete Response) | 1/Arm 1-Axitinib | Complete Response | 0 | Participants | |
| Number of Participants With Clinical Response (Partial Response + Complete Response) | 1/Arm 1-Axitinib | Stable Disease | 5 | Participants | |
| Number of Participants With Clinical Response (Partial Response + Complete Response) | 1/Arm 1-Axitinib | Progressive Disease | 2 | Participants | |
| Progression - Free Survival (PFS) | 1/Arm 1-Axitinib | 7.7 | 95% Confidence Interval 3.3 to 16.8 | months | |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | 1/Arm 1-Axitinib | 14 | 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 | 1/Arm 1-Axitinib | 14 | |
| Overall Study | COMPLETED | 1/Arm 1-Axitinib | 7 | |
| Overall Study | NOT COMPLETED | 1/Arm 1-Axitinib | 7 |
Source ClinicalTrials.gov
Adverse events150
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 | 1/Arm 1-Axitinib | 6 | 14 | 16 |
| other | Activated partial thromboplastin time prolonged | Investigations | 1/Arm 1-Axitinib | 2 | 14 | 4 |
| other | Acute kidney injury | Renal and urinary disorders | 1/Arm 1-Axitinib | 1 | 14 | 1 |
| other | Alanine aminotransferase increased | Investigations | 1/Arm 1-Axitinib | 5 | 14 | 7 |
| other | Alkaline phosphatase increased | Investigations | 1/Arm 1-Axitinib | 7 | 14 | 11 |
| other | Allergic reaction | Immune system disorders | 1/Arm 1-Axitinib | 1 | 14 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | 1/Arm 1-Axitinib | 3 | 14 | 3 |
| other | Anemia | Blood and lymphatic system disorders | 1/Arm 1-Axitinib | 10 | 14 | 30 |
| other | Anorexia | Metabolism and nutrition disorders | 1/Arm 1-Axitinib | 5 | 14 | 10 |
| other | Anxiety | Psychiatric disorders | 1/Arm 1-Axitinib | 1 | 14 | 1 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1/Arm 1-Axitinib | 9 | 14 |
| Total, other adverse events | 1/Arm 1-Axitinib | 14 | 14 |
| Total, serious adverse events | 1/Arm 1-Axitinib | 2 | 14 |
Source ClinicalTrials.gov
Papers4
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/NCT01967576
GET https://conductscience.org/api/trials/v1/NCT01967576/events?page=2