Sunitinib in Refractory Adrenocortical Carcinoma (SIRAC)
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|ClinicalTrials.gov Identifier: NCT00453895|
Recruitment Status : Completed
First Posted : March 29, 2007
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
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 or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sunitinib in Refractory Adrenocortical-Carcinoma Patients Progressing After Cytotoxic Chemotherapy|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||February 2012|
Sunitinib will be administered 50 mg per day for 4 weeks followed by 2 weeks off.
treatment will continue until progressive disease or unacceptable toxicity
- Assessment of Clinical Benefit Due to Treatment With Sunitinib [ Time Frame: 12 weeks ]Clinical benefit was defined as stable disease or better for at least 12 weeks
- Assessment of Objective Response Rates [ Time Frame: 12 weeks ]Objective Response Rate defined by RECIST 1.0
- Assessment of Progression-free Survival [ Time Frame: up to 400 days ]Progression-free survival is defined as time of start of study until documentation of Progress. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Assessment of Overall Survival [ Time Frame: up to 36 months ]Overall Survival was defined as time from start of treatment until death or last follow-up.
- Assessment of Toxicity [ Time Frame: up to 400 days ]Adverse events were rated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (see http://ctep.cancer.gov/reporting/ctc.html).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453895
|Dept. of Medicine I, University of Wuerzburg|
|Wuerzburg, Germany, 97080|
|Principal Investigator:||Martin Fassnacht, MD||University of Wuerzburg|