Actively Recruiting
Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma
Led by Qingdao Central Hospital · Updated on 2023-03-29
20
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenoid cystic carcinoma
- Local, locally-advanced, or metastatic disease with progression documented on scan within 2 to 12 months prior to baseline
- Disease not suitable for surgery, radiation, or combined therapy with curative intent
- Previously treated with chemotherapy or local treatments such as transarterial chemoembolization
- At least one measurable target lesion per RECIST criteria
- Age 18 years or older
- ECOG performance status 0, 1, 2, or 3
- Previous treatments must have resolved toxicity to grade 1 or less and be at least 4 weeks prior to baseline
- Adequate organ function
- Willing and able to comply with the study protocol
- Signed informed consent and understands the right to withdraw at any time
You will not qualify if you...
- No measurable disease or allergy to EGFR TKIs
- Chemotherapy, radiation, or surgery within 4 weeks prior to study entry, except palliative radiotherapy within 2 weeks
- Intestinal obstruction or impending obstruction, recent active upper gastrointestinal bleeding
- Pregnant or lactating women
- Childbearing potential without negative pregnancy test at baseline
- Men or women of childbearing potential unwilling to use contraception during the study
- History of uncontrolled seizures, significant central nervous system or psychiatric disorders interfering with informed consent or compliance
- Clinically significant heart disease or myocardial infarction within the past 12 months
- Ongoing cardiac arrhythmia grade 2 or higher, atrial fibrillation of any grade, or prolonged QTc interval (>450 msec for males, >470 msec for females)
- Interstitial pneumonia or diffuse symptomatic lung fibrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qingdao central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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