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

Phase 2
18 Years
Open (Enrolling)
Adenoid Cystic Carcinoma

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Trial Information

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

Inclusion Criteria:

- Patients must have MSKCC pathologically confirmed adenoid cystic carcinoma. Cancers
arising from non-salivary gland primary sites are allowed.

- Patients must have locally advanced and/or recurrent and/or metastatic disease not
amenable to potentially curative surgery or radiotherapy.

- At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks
for bevacizumab- containing regimens), radiotherapy, or surgical procedure with
resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or
tolerable grade 2) or back to baseline except for alopecia or hypothyroidism.

- Patients must have RECIST v1.1 measurable disease, defined as at least one lesion
that can be accurately measured in at least one dimension (longest diameter to be
recorded for non-nodal lesions and short axis for nodal lesions) as > or = to 20 mm
with conventional techniques or as > or = to 10 mm with spiral CT scan.

- Patients must have documentation of a new or progressive lesion on a radiologic
imaging study performed within 6 months prior to study enrollment (progression of
disease over any interval is allowed) and/or new/worsening disease related symptoms.
Note: This assessment will be performed by the treating investigator. Evidence of
progression by RECIST criteria is not required.

- Patients must have archival tissue from the primary tumor or metastases available for
correlative studies. Either a paraffin block or twenty unstained slides containing
5μm sections are acceptable. If twenty slides are not available, a lesser amount may
be acceptable after discussion with the study Principal Investigator, Dr. Alan L. Ho.

- Male or female, age > or = to 18 years.

- ECOG performance status < or = to 2 (Karnofsky > or = to 60%, see Appendix A).

- Life expectancy of ≥ 12 weeks.

Adequate organ function as defined by the following criteria:

- absolute neutrophil count (ANC) > 1000 cells/mm3

- platelets > or = to 75,000 cells/mm3

- Hemoglobin > or = to 9.0 g/dL

- AST and ALT < or = to 2.5 x upper limit of normal (ULN), unless there are liver
metastases in which case AST and ALT < 5.0 x ULN

- Total bilirubin < or = to 1.5 x ULN

- Serum creatinine < or = to 1.5 x ULN or calculated creatinine clearance > or = to 60

- Urinary protein < 2+ by urine dipstick. If dipstick is > or = to 2+ then a 24-hour
urine collection can be done and the patient may enter only if urinary protein is < 2
g per 24 hours.

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry, for the duration of study participation, and for 6 months after
discontinuing study treatment.

Exclusion Criteria:

- Major surgery < 2 weeks or radiation therapy < 2 weeks of starting the study

- Gastrointestinal abnormalities including:

- inability to take oral medication;

- malabsorption syndromes.

- Current use or anticipated need for treatment with drugs that are known potent CYP3A4
inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole,
itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir,
ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and

- Current use or anticipated need for treatment with drugs that are known CYP3A4 or
CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole,
phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin,
and St. John's wort)

- Requirement for anticoagulant therapy with oral vitamin K antagonists. Low-dose
anticoagulants for maintenance of patency of central venous access devise or
prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular
weight heparin is allowed.

- Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis.

- A serious uncontrolled medical disorder or active infection that would impair their
ability to receive study treatment.

- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
attack and 6 months for deep vein thrombosis or pulmonary embolism.

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness.

- Dementia or significantly altered mental status that would prohibit the understanding
or rendering of informed consent and compliance with the requirements of this

- Female patients who are pregnant or lactating.

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results, and
in the judgment of the investigator would make the patient inappropriate for entry
into this study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Alan L. Ho, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Adenoid Cystic Carcinoma
  • axitinib (AG-013736)
  • recurrent
  • metastatic
  • 12-004
  • Carcinoma
  • Carcinoma, Adenoid Cystic



Memorial Sloan-Kettering Cancer Center New York, New York  10021