Salivary Gland Carcinoma
Conditions
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.
Interventions
DRUGpazopanib
treatment will be given until progression or unacceptable toxicity .
Sponsors
UNICANCER
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \>10 mm. * 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. * Euthyroid 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) \>480 msecs using Bazett's formula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 6 months |
Countries
France
Outcome results
None listed