Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
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|ClinicalTrials.gov Identifier: NCT01558661|
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: AG-013736 (AXITINIB)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
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.
- Overall Response Rate [ Time Frame: 2 years ]Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 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; Complete Response (CR), Disappearance of all target lesions
- Median Progression-free Survival (PFS). [ Time Frame: 2 years ]Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. 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"
- MYB Immunohistochemistry (IHC) [ Time Frame: 2 years ]
- Number of Participants With Next Generation Sequencing (NGS) [ Time Frame: 2 years ]Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded.
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): 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|