BridgeMD
New treatment option for Carcinoma, Adenoid Cystic
Official title Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma
ClinicalTrials.gov ID: NCT04974866
What this study is testing
What is EGFR-TK Inhibitor?
EGFR-TK Inhibitor is an investigational medicine, being studied as a potential treatment for carcinoma, adenoid cystic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Disease that is not amenable to surgery, radiation or combined modality therapy with curative intent and who is previously treated with chemotherapy...
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria
- 18 years or older
You likely can't join if
- 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...
- 10\. A patient with clinically significant heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmia...
- 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
See the full eligibility criteria
- 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...
- 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
- 18 years or older
- ECOG performance status 0, 1, 2, 3
- 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...
- Adequate organ function
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.