Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Adenoid Cystic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Adenoid Cystic Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Antihypertensive Agents

Axitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

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).

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.

AG-013736 (AXITINIB)

Alan L. Ho, MD, PhD

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.

Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

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

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"

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.

National Comprehensive Cancer Network

Pfizer

Memorial Sloan Kettering Cancer Center

Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Alan Ho, MD, PhD

One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not for Progression Free Survival.

Overall Response Rate

One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.

Median Progression-free Survival (PFS).

MYB immunohistochemistry (IHC) was carried out on tumors from 33 patients. MYB quantification was assessed as: 2+ for strong staining in \>50% of cancer cells, 1+ for weak or strong staining in \<50% of the cells and 0 for \<5% staining.

Spots Global Cancer Trial Database for Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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