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NCT01967576 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma
A Phase 2 study of Pheochromocytoma and Paraganglioma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT01967576 is a Phase 2 study of Pheochromocytoma and Paraganglioma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01967576, a Phase 2 study of Pheochromocytoma and Paraganglioma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Most treatments for malignant pheochromocytomas/paragangliomas (PHEO/PGL) are palliative and multidisciplinary. Chemotherapy using the combination of cyclophosphamide, vincristine, and dacarbazine has been successfully utilized in the management of rapidly progressive metastatic PHEO, with more than 50% complete or partial tumor response and more than 70% complete or partial biochemical response. * Vascular endothelial growth factor (VEGF) expression and evidence of angiogenesis has been found in many PHEO/PGL, so it is plausible that interfering with VEGF signaling may result in anti-tumor activity in patients with PHEO/PGL. * Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. Pre-clinical data suggests that the anti-tumor activity of axitinib may result from its anti-angiogenic activity and that this is reversible when treatment is discontinued. * Given the known clinical safety and efficacy of axitinib, an assessment of its activity in PHEO/PGL and its impact on the VEGF pathway in PHEO/PGL could provide valuable information. Objectives: * Determine the response rate of metastatic PHEO/PGL to axitinib (AG-013736). * Determine the progression-free survival of metastatic PHEO/PGL treated with axitinib (AG-013736). * Explore the relationship of potential biological markers of axitinib activity with clinical outcomes. * Perform pharmacogenomics analyses of drug metabolism and transport proteins through germline deoxyribonucleic acid (DNA) examination. Eligibility: * Adults with a confirmed pathologic diagnosis of PHEO/PGL by the Laboratory of Pathology, National Cancer Institute (NCI) * Biochemical evidence of PHEO/PGL * Imaging confirmation of metastatic, locally advanced or unresectable disease. * Measurable disease at presentation * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Patients must not have received prior therapy wi
Conditions Studied
Interventions
- DRUG Axitinib (AG-013736)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-10-19 |
| Est. Completion | 2020-12-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01967576
The ClinicalTrials.gov registry entry for NCT01967576 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 519-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pheochromocytoma appearing as the primary indexed condition, and to 1 intervention - of which Axitinib (AG-013736) is the first listed.
NCT01967576 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01967576 about?
NCT01967576 is a clinical study titled "Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma". Background: * Most treatments for malignant pheochromocytomas/paragangliomas (PHEO/PGL) are palliative and multidisciplinary. Chemotherapy using the combination of cyclophosphamide, vincristine, and dacarbazine has been successfully utilized in the management of rapidly progressive metastatic PHEO,...
What is the current status of trial NCT01967576?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2013-10-19. Estimated completion is 2020-12-01.
What conditions does trial NCT01967576 study?
This clinical trial studies the following conditions: Pheochromocytoma, Paraganglioma.
What interventions are being tested in trial NCT01967576?
The interventions under investigation include: Axitinib (AG-013736) (DRUG).
Who is sponsoring clinical trial NCT01967576?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01967576 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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