Clinical trial · Interventional
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Phase II Study of Imatinib (Glivec) Administered as a Daily Oral Treatment in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck Overexpressing KIT
NCT00180921CI-TRIAL-00000888unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II study of imatinib (Glivec) administered as a daily oral treatment in patients with recurrent/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Carcinoma, Adenoid Cystic | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess progression-free survival under treatment with imatinib mesylate in patients with relapsing/metastatic adenoid cystic carcinoma of the head and neck overexpressing KIT.
- timeFrame
- at 6 months
Secondary outcomes (1)
- measure
- The secondary objectives are to estimate the objective response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria), disease control and overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI). * Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter \>= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment). * Patients able to swallow an oral compound. * World Health Organization (WHO) performance status \< 2. * Life expectancy of \>= 3 months. * Aged \>= 18 years. * Normal hematological (neutrophils \>= 1.5 x 10\^9 cells/l, platelets \>= 100 x 10\^9 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases \<= 2.5 x the upper limit of the normal range) and renal (serum creatinine \<= 150 mmol/l) functions. * Written informed consent. Exclusion Criteria: * Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG). * Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. * Concomitant treatment with warfarin or any other anticoagulants. * Unstable systemic diseases or active uncontrolled infections. * Patients (male and female) not using effective contraception if of reproductive potential. * Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline
References
Publications (0)
Data not yet available
No reference posted for this study.