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Spots Global Cancer Trial Database for Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

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Trial Identification

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

Interventions

pazopanib

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Joel Mr Guigay, Pr

Affiliation: Centre Lacassagne Nice

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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