Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorQingdao Central Hospital

About this trial

There is no clinical study on epidermal growth factor receptor tyrosine kinase inhibitors has been systematically conducted in adenoid cystic carcinoma.

This is a phase II study EGFR TKIs in adenoid cystic carcinoma to evaluate its efficacy in this disease.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed adenoid cystic carcinoma

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.

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)

Presence of at least one measurable target lesion for further evaluation according to RECIST criteria

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • EGFR-TK Inhibitor

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators