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Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma

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ClinicalTrials.gov Identifier: NCT04974866
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Youxin Ji, Qingdao Central Hospital

Brief Summary:

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Tyrosine

Arm Intervention/treatment
Experimental: study drug
EGFR TKIs
Drug: EGFR-TK Inhibitor
epidermal growth factor receptor tyrosine kinase inhibitors




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 10 months ]
    progression free survival


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
    overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

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


Locations
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China, Shandong
Qingdao central Hospital Recruiting
Qingdao, Shandong, China, 266042
Contact: Youxin Ji, MD    68665078    ji6677@gmail.com   
Sponsors and Collaborators
Qingdao Central Hospital
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Responsible Party: Youxin Ji, chief, Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT04974866    
Other Study ID Numbers: QDCH2021-07-01
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Youxin Ji, Qingdao Central Hospital:
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma