Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04974866|
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : July 23, 2021
no clinical study on epidermal growth factor receptor tyrosine kinase inhibitors has been systematically conducted in adenoid cystic carcinoma.
We design this phase II study EGFR TKIs in adenoid cystic carcinoma to evaluate its efficacy in this disease.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Adenoid Cystic||Drug: EGFR-TK Inhibitor||Phase 2|
The histologic appearance of adenoid cystic carcinoma is low grade, management of this malignancy is a challenge because of its insidious local growth pattern and lack of effency with chemotherapy or radiotherapy in metastatic disease.
In other performed clinical trials, objective responses to any cytotoxic agent or regimen are infrequent, whereas stabilization of disease was observed more commonly.
In adenoid cystic carcinoma, the study focusing on EGFR pathway is rare. According to previous study, adenoid cystic carcinoma cell lines have increased pAkt activity when EGF-stimulation is added. And when treated with EGFR/VEGFR TK dual inhibitor, the phosphorylated form of Akt decreased despite of total level of Akt is remained unchanged.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tyrosine Kinase Inhibitors in the Management of Local Advanced or Metastastic Adenoid Cystic Carcinoma|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||July 31, 2026|
Experimental: study drug
Drug: EGFR-TK Inhibitor
epidermal growth factor receptor tyrosine kinase inhibitors
- progression free survival [ Time Frame: 10 months ]progression free survival
- overall survival [ Time Frame: 2 years ]overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974866
|Qingdao central Hospital||Recruiting|
|Qingdao, Shandong, China, 266042|
|Contact: Youxin Ji, MD 68665078 email@example.com|