Salivary Gland Carcinoma Clinical Trial
Official title:
Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03942653 -
Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma
|
Phase 2 | |
| Completed |
NCT03132038 -
Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
|
Phase 2 | |
| Completed |
NCT03602079 -
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
|
Phase 1/Phase 2 | |
| Completed |
NCT03749460 -
Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05075980 -
HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers
|
Phase 2 | |
| Recruiting |
NCT03942380 -
Cell-free Tumor DNA in Head and Neck Cancer Patients
|
N/A | |
| Withdrawn |
NCT04832438 -
9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma
|
Phase 2 | |
| Recruiting |
NCT02628067 -
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
|
Phase 2 |