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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborators: |
National Comprehensive Cancer Network Pfizer |
| Information provided by (Responsible Party): | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01435122 |
Purpose
The main purpose of this study is to see whether Axitinib will help prolong the time that the patient's carcinoid tumors remain stable, and to examine their treatment response through testing. Researchers also want to find out if Axitinib is safe and tolerable.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoid Tumor |
Drug: Axitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Axitinib in Advanced Carcinoid Tumors |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Axitinib Administration
The investigational drug used in this study is axitinib, and is available as tablets. You will take the tablet orally with food. Doses should be taken around 12 hours apart continuously, without scheduled breaks. If you vomit anytime after taking a dose do not take another tablet to "make up the dose" but instead continue taking your next dose as planned. Any missed dose may be taken late (up to 3 hours before the next scheduled dose); otherwise it should be skipped. If doses are missed or vomited, please keep track of this and report at your next visit. |
Drug: Axitinib
Axitinib Administration as outlined in Arm description
Other Names:
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This is a bi-institutional, prospective phase II, open-label study. The target population is comprised of adult patients with histologically confirmed unresectable or metastatic carcinoid tumors. Carcinoid tumors are defined as well to moderately differentiated neuroendocrine tumors of the digestive tract and lungs. Patients with metastatic carcinoid tumors of unknown primary as well as rare primaries (renal, ovarian, thymic, hepatic) will also be eligible. Patients will be drawn from two institutions Moffitt Cancer Center (MCC) and The University of California, San Francisco (UCSF).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jonathan Strosberg, M.D. | 813-745-7257 | jonathan.strosberg@moffitt.org |
| United States, California | |
| University of California San Francisco (UCSF) | Not yet recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Iche Siah 415-353-7792 isiah@medicine.ucsf.edu | |
| Principal Investigator: Emily Bergsland, M.D. | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Tiffany Campos 813-745-8358 tiffany.campos@moffitt.org | |
| Principal Investigator: Jonathan Strosberg, M.D. | |
| Sub-Investigator: Larry Kvols, M.D. | |
| Principal Investigator: | Jonathan Strosberg, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01435122 History of Changes |
| Other Study ID Numbers: | MCC-16692 |
| Study First Received: | September 14, 2011 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
progressive advanced carcinoid tumors advanced unresectable metastatic cancerous tumors neuroendocrine |
digestive tract lungs renal ovarian thymic hepatic |
|
Carcinoid Tumor Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |