This trial is active, not recruiting.

Condition salivary gland carcinoma
Treatment pazopanib
Phase phase 2
Start date August 2013
End date February 2017
Trial size 72 participants
Trial identifier NCT02393820, 2012-004408-36, UC-0130/1205


Open-label, multicenter, single arm phase II study, set up in collaboration with the 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Pazopanib per os, 800mg daily until progression
pazopanib Votrient
treatment will be given until progression or unacceptable toxicity .

Primary Outcomes

progression free survival
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC) - Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST V1.0) with at least one measurable target lesion >10mm. - Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment. - Patients may have had unlimited prior therapy but must have had at least 4-weeks between any chemotherapy, radiotherapy, surgery and study enrollment. - Tumoral tissue must be provided for subsequent histological review and biomarker analysis. - Euthyroidie patient - Hepatic, Renal, cardiac and hematology normal functions - Ability to take oral medication Exclusion Criteria: - Non salivary gland carcinoma (lachrymal gland tumor is excluded) - Known or symptomatic cerebral metastasis - Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion - Presence of uncontrolled infection - Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma - Stable disease - Corrected QT interval (QTc)> 480msecs using Bazett's formula

Additional Information

Official title Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Principal investigator Joel Mr Guigay, Pr
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by UNICANCER.