| Eligibility |
Inclusion Criteria:
1. Histologically or cytologically confirmed adenoid cystic carcinoma
2. Local, locally-advanced or metastatic disease documented as having shown progression
on a scan (CT, MRI, MIBI scan) taken 2 to 12 months prior to baseline compared to a
previous scan taken at any time in the past. Progression must be documented according
to RECIST criteria.
3. Disease that is not amenable to surgery, radiation or combined modality therapy with
curative intent and who is previously treated with chemotherapy or local treatment
(e,g transarterial chemoembolization)
4. Presence of at least one measurable target lesion for further evaluation according to
RECIST criteria
5. 18 years or older
6. ECOG performance status 0, 1, 2, 3
7. Previous treatment with chemotherapy, loco-regional therapy (e.g chemoembolization)
are permitted providing that toxicity has resolved to =grade 1 at study entry and that
last treatment was at least 4 weeks prior to baseline assessment.
8. Adequate organ function
9. A patient with the willingness to comply with the study protocol during the study
period and capable of complying with it
10. A patient who signed the informed consent prior to the participation of the study and
who understands that he/she has a right to withdrawal from participation in the study
at any time without any disadvantages.
Exclusion Criteria:
- 1. A patient with no measurable disease, or allergy to the EGFR TKIs 2. Prior
chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except
palliative radiotherapy to non-target lesions (within 2 weeks prior to study entry) 4.
A patient with intestinal obstruction or impending obstruction, recent active upper GI
bleeding 5. A pregnant or lactating patient 6. A patient of childbearing potential
without being tested for pregnancy at baseline or with being tested for positive. (A
postmenopausal woman with the amenorrhea period of at least 12 months or longer is
considered to have non-childbearing potential) 7. A man or woman of childbearing
potential who has no willingness to use a contraceptive measure during the study 9. A
patient with history of uncontrolled seizures, central nervous system disorder or
psychiatric disorders that are considered clinically significant by the investigator
that would prohibit the understanding of informed consent or that may be considered to
interfere with the compliance of the administration of the study medications.
10. A patient with clinically significant heart disease (e.g. congestive heart
failure, symptomatic coronary artery diseases, cardiac arrhythmia, etc) or myocardial
infarction within past 12 months.
11. Ongoing cardiac arrhythmia of grade =2, atrial fibrillation of any grade, or QTc
interval>450msec for males or >470msec for female.
12. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
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