Phase
Condition
Carcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 MRIusing at least two measurements (RECIST v1.0) with at least one measurable targetlesion >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 weeksbetween any chemotherapy, radiotherapy, surgery and study enrollment.
Tumoral tissue must be provided for subsequent histological review and biomarkeranalysis.
Euthyroid patient.
Hepatic, renal, cardiac and hematology normal functions.
Ability to take oral medication.
Exclusion
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 beforeinclusion.
Presence of uncontrolled infection.
Diagnosis of any previous malignancy within the last 5 years, except for completelyresected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
Stable disease.
Corrected QT interval (QTc) >480 msecs using Bazett's formula.
Study Design
Study Description
Connect with a study center
Institut de Cancérologie de l'Ouest Paul Papin
Angers, 49933
FranceSite Not Available
CHU Bordeaux
Bordeaux, 33075
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand, 63011
FranceSite Not Available
Centre Georges François Leclerc
Dijon, 21079
FranceSite Not Available
Centre Oscar Lambret
Lille, 59020
FranceSite Not Available
Centre Léon Bérard
Lyon, 69373
FranceSite Not Available
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
Centre Hospitalier St Joseph
Paris, 75674
FranceSite Not Available
Institut Curie
Paris, 75231
FranceSite Not Available
Centre Eugène Marquis
Rennes, 35042
FranceSite Not Available
Institut Curie site St Cloud
Saint Cloud, 92210
FranceSite Not Available
Institut Cancérologie de l'Ouest
Saint-herblain, 48805
FranceSite Not Available
Centre Paul Strauss
Strasbourg, 67065
FranceSite Not Available
Gustave Roussy
Villejuif, 94
FranceSite Not Available

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