Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
The purpose of this study is to find out what effects, good and/or bad, a new treatment called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is called a phase II study.
Axitinib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if axitinib is a useful drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug that has not yet been approved by the Food and Drug Administration for use in adenoid cystic carcinoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma|
- overall response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib.
- median progression-free survival (PFS). [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
- ACC tumor responses [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate the hypothesis that ACC tumor responses to axitinib are correlated to baseline expression of PDGFR and/or c-myb driven expression of c-kit and VEGFR. Levels of c-kit, VEGF, VEGFR-2, PDGF, PDGFRα/β, and c-myb in archival tumor tissue will be quantified by immunohistochemistry (IHC) and their association with objective response to axitinib will be investigated using the non-parametric Wilcoxon signed-rank test.
- ACC tumors harboring [ Time Frame: 2 years ] [ Designated as safety issue: No ]the t(6;9) translocation (MYBNFIB gene product) are more likely to respond to axitinib.t(6;9) translocation status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response.
|Study Start Date:||March 2012|
|Study Completion Date:||August 2016|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: AG-013736 (AXITINIB)
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Drug: AG-013736 (AXITINIB)
All eligible patients will receive a starting axitinib dose of 5 mg twice daily (BID) taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above CTCAE v. 4.0 Grade 2 for a consecutive 2-week period may have their dose increased by one dose level according to the discretion of the treating physician (NOT allowed for patients with blood pressure (BP) > 150/90 mm Hg or who are receiving antihypertensive medication). This dose escalation is not mandatory. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558661
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Alan L. Ho, MD, PhD||Memorial Sloan Kettering Cancer Center|