Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02393820
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
* Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion \>10 mm.
* Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
* Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
* Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
* Euthyroid patient.
* Hepatic, renal, cardiac and hematology normal functions.
* Ability to take oral medication.
Exclusion Criteria:
* Non salivary gland carcinoma (lachrymal gland tumor is excluded).
* Known or symptomatic cerebral metastasis.
* Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
* Presence of uncontrolled infection.
* Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
* Stable disease.
* Corrected QT interval (QTc) \>480 msecs using Bazett's formula.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02393820
Study Brief:
Protocol Section:
NCT02393820