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NCT01255137 · 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 Adrenocortical Cancer
A Phase 2 study of Adrenal Cortex Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01255137 is a Phase 2 study of Adrenal Cortex Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01255137, a Phase 2 study of Adrenal Cortex Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the top of the kidneys. It has a low survival rate if standard treatment options are not effective. Axitinib is an experimental drug that is being studied to determine if it can stop tumors from growing or make them smaller. Researchers are interested in investigating axitinib in individuals with aggressive or otherwise untreatable adrenocortical cancer. Objectives: \- To evaluate the effectiveness of axitinib in individuals who have adrenocortical cancer that is inoperable and has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with adrenocortical cancer that has not responded to standard treatments. Design: * Participants will be screened with a full physical examination and medical history, as well as tumor imaging studies. * Participants may have a tumor biopsy prior to starting axitinib. * All participants will receive axitinib to take twice a day with food for 28 days (1 cycle). Participants should not drink grapefruit juice or smoke cigarettes while participating in this study. * After the first cycle, the dose may be increased and additional cycles will be given if the treatment has not had serious side effects. * Participants will have regular examinations while taking axitinib, including blood samples and tumor imaging studies to determine if the tumor has stopped growing. Blood pressure levels will be carefully monitored during treatment to evaluate potential risk for high blood pressure. * Participants may have a second tumor biopsy 20 to 30 days after treatment begins. * Treatment will continue as directed by the study researchers.
Conditions Studied
Interventions
- DRUG Axitinib
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01255137
The ClinicalTrials.gov registry entry for NCT01255137 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adrenal Cortex Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Axitinib is the first listed.
NCT01255137 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01255137 about?
NCT01255137 is a clinical study titled "Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer". Background: \- Adrenocortical carcinoma is an aggressive cancer that starts in the adrenal gland at the top of the kidneys. It has a low survival rate if standard treatment options are not effective. Axitinib is an experimental drug that is being studied to determine if it can stop tumors from grow...
What is the current status of trial NCT01255137?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2010-09. Estimated completion is 2012-12.
What conditions does trial NCT01255137 study?
This clinical trial studies the following conditions: Adrenal Cortex Neoplasms.
What interventions are being tested in trial NCT01255137?
The interventions under investigation include: Axitinib (DRUG).
Who is sponsoring clinical trial NCT01255137?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01255137 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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