A Phase 2 interventional study of pazopanib in Salivary Gland Carcinoma, sponsored by UNICANCER. Completed at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
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).
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 72 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pazopanib per os, 800mg daily until progression
Drug: pazopanib
treatment will be given until progression or unacceptable toxicity .
Also known as: Votrient
progression free survival
Time frame: 6 months
Plan to share: No — Individual Participant Data (IPD) will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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