The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Official Title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Study ID: NCT02393820
Brief Summary: Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).
Detailed Description: In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion. ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%. 43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective. If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising. The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07. Analysis of results will be separated between non ACC and ACC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut de Cancérologie de l'Ouest Paul Papin, Angers, , France
CHU Bordeaux, Bordeaux, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Bérard, Lyon, , France
Centre Val d'Aurelle Paul Lamarque, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Centre Hospitalier St Joseph, Paris, , France
Centre Eugène Marquis, Rennes, , France
Institut Curie site St Cloud, Saint Cloud, , France
Institut Cancérologie de l'Ouest, Saint-herblain, , France
Centre Paul Strauss, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Name: Joel Mr Guigay, Pr
Affiliation: Centre Lacassagne Nice
Role: PRINCIPAL_INVESTIGATOR