Using Tyrosine Kinase Inhibitors for Metastatic Adenoid Cystic Carcinoma
Tyrosine Kinase Inhibitors in the Management of Local Advanced or Metastastic Adenoid Cystic Carcinoma
This study is testing if a new type of medication can help people with advanced adenoid cystic carcinoma by slowing down or improving their cancer progression.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Qingdao Central Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT04974866 on ClinicalTrials.gov |
What this trial studies
This phase II study evaluates the efficacy of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in patients with metastatic adenoid cystic carcinoma. The study aims to address the challenges in managing this low-grade malignancy, which often shows resistance to conventional chemotherapy and radiotherapy. By focusing on the EGFR pathway, the trial seeks to determine whether these inhibitors can stabilize or improve disease progression in affected patients. Participants will be monitored for measurable target lesions to assess treatment response according to RECIST criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed metastatic adenoid cystic carcinoma that has shown progression despite previous treatments.
Not a fit: Patients with early-stage adenoid cystic carcinoma that is amenable to surgery or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic adenoid cystic carcinoma who have limited treatment choices.
How similar studies have performed: While there is limited research specifically on EGFR TKIs in adenoid cystic carcinoma, other studies have shown promise in targeting similar pathways in different cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Qingdao, Shandong
- Qingdao central Hospital — Qingdao, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.