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RecruitingNCT04974866Updated Mar 29, 2023

Tyrosine Kinase Inhibitors in Metastastic Adenoid Cystic Carcinoma

A Phase 2 interventional study of EGFR-TK Inhibitor in Carcinoma, Adenoid Cystic, sponsored by Qingdao Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Qingdao Central Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jul 2021; still recruiting 5 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carcinoma, Adenoid Cystic

Keywords

  • Neoplasms, Glandular and Epithelial
  • Adenocarcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Qingdao Central Hospital is the lead sponsor of 23 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

      1. 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.
      1. Ongoing cardiac arrhythmia of grade ≥2, atrial fibrillation of any grade, or QTc interval>450msec for males or >470msec for female.
      1. A patient with interstitial pneumonia or diffuse symptomatic fibrosis of the lungs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    study drug

    EGFR TKIs

    Drug: EGFR-TK Inhibitor

Interventions

  • DrugEGFR-TK Inhibitor

    epidermal growth factor receptor tyrosine kinase inhibitors

06

What researchers measure

Primary outcomes

  1. progression free survival

    progression free survival

    Time frame: 10 months

Secondary outcomes

  1. overall survival

    overall survival

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Qingdao central Hospital
    Qingdao, Shandong 266042, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04974866
Lead sponsor
Qingdao Central Hospital
Responsible party
Youxin Ji (chief, Qingdao Central Hospital) — Principal investigator
First posted
Jul 23, 2021
Start date
Jul 1, 2021
Primary completion
Jul 31, 2024 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Mar 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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