Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma

  • STATUS
    Recruiting
  • End date
    Jul 31, 2026
  • participants needed
    20
  • sponsor
    Qingdao Central Hospital
Send
Updated on 15 November 2021
See if I qualify
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Adenoid Cystic Carcinoma
Treatment EGFR-TK Inhibitor
Clinical Study IdentifierNCT04974866
SponsorQingdao Central Hospital
Last Modified on15 November 2021

Eligibility

 Yes No Not Sure

Inclusion 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. 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
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 baseline assessment
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

Exclusion Criteria

\. 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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note