NCT02393820

Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Salivary Gland Carcinoma

Interventions

Type	Name	Description
DRUG	pazopanib	treatment will be given until progression or unacceptable toxicity .

Timeline

• Start date: 2013-08-26
• Primary completion: 2015-12-31
• Completion: 2019-10-01
• First posted: 2015-03-19
• Last updated: 2019-10-29

Locations

15 sites across 1 country: France