Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma (PACSA (ORL02))
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|ClinicalTrials.gov Identifier: NCT02393820|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Carcinoma||Drug: pazopanib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma|
|Actual Study Start Date :||August 26, 2013|
|Actual Primary Completion Date :||December 31, 2015|
|Estimated Study Completion Date :||September 2019|
Pazopanib per os, 800mg daily until progression
treatment will be given until progression or unacceptable toxicity .
Other Name: Votrient
- progression free survival [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393820
|Institut de Cancérologie de l'Ouest Paul Papin|
|Angers, France, 49933|
|Bordeaux, France, 33075|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Georges François Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Léon Bérard|
|Lyon, France, 69373|
|Centre Val d'Aurelle Paul Lamarque|
|Montpellier, France, 34298|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Paris, France, 75231|
|Centre Hospitalier St Joseph|
|Paris, France, 75674|
|Centre Eugène Marquis|
|Rennes, France, 35042|
|Institut Curie site St Cloud|
|Saint Cloud, France, 92210|
|Institut Cancérologie de l'Ouest|
|Saint-herblain, France, 48805|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Villejuif, France, 94|
|Principal Investigator:||Joel Mr Guigay, Pr||Centre Lacassagne Nice|