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Sponsors and Collaborators: |
University of Wuerzburg Pfizer |
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Information provided by: | University of Wuerzburg |
ClinicalTrials.gov Identifier: | NCT00453895 |
Although a first randomized trial in patients with advanced ACC leading to the establishment of a first line cytotoxic chemotherapy is ongoing (FIRM-ACT), the failure rate even of this FIRM-ACT study is most likely clearly above 50%. Therefore, the majority of participating patients urgently need a new treatment option. However, up to date there is no evidence for a single regimen that might be promising in these treatment-refractory patients with ACC. Sunitinib is an oral multitargeted tyrosine kinase inhibitor with anti-tumor and antiangiogenic activities, which is successfully tested in the treatment of patients with metastatic renal cell carcinoma, gastrointestinal stromal and neuroendocrine tumors after failure of standard cytotoxic chemotherapy.
The primary objective of this trial is to estimate the response (defined as progression-free survival of ≥ 12 weeks) rate associated with Sunitinib treatment in patients advanced ACC progressing after cytotoxic chemotherapy.
Condition | Intervention | Phase |
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Adrenocortical Carcinoma |
Drug: Sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy |
Estimated Enrollment: | 36 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
FIRM-ACT), the patient can only be included in the SIRAC trial, if:
Exclusion Criteria:
Contact: Martin Fassnacht, MD | 49-931-201-36507 | fassnacht_m@medizin.uni-wuerzburg.de |
Contact: Marcus Quinkler, MD | 49-30-450-514259 | marcus.quinkler@charite.de |
Germany | |
Dept. of Medicine I, University of Wuerzburg | Recruiting |
Wuerzburg, Germany, 97080 | |
Contact: Martin Fassnacht, MD 49-931-201-36507 fassnacht_m@medizin.uni-wuerzburg.de | |
Principal Investigator: Martin Fassnacht, MD | |
Charite Berlin | Recruiting |
Berlin, Germany | |
Contact: Marcus Quinkler, MD 49-30-450-514259 marcus.quinkler@charite.de | |
Principal Investigator: Marcus Quinkler, MD |
Principal Investigator: | Martin Fassnacht, MD | University of Wuerzburg |
Study ID Numbers: | SIRAC-1 |
Study First Received: | March 28, 2007 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00453895 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Adrenal cancer refractory to cytotoxic therapy Sunitinib Multitargeted tyrosine-kinase inhibitor |
Adrenocortical Carcinoma Tyrosine Adrenal Gland Diseases Endocrine System Diseases Angiogenesis Inhibitors Carcinoma Adrenal Gland Neoplasms Sunitinib |
Adrenal Cancer Adrenal Cortex Neoplasms Endocrinopathy Epinephrine Adenocarcinoma Adrenal Cortex Diseases Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Adrenocortical Carcinoma Physiological Effects of Drugs Adrenal Gland Diseases Endocrine System Diseases Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Adrenal Gland Neoplasms Neoplasms by Site Sunitinib Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Adrenal Cortex Neoplasms Adenocarcinoma Adrenal Cortex Diseases Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |