A Phase 2 interventional study of biopsies and SU011248 in Recurrent Disease, Squamous Cell Head and Neck Carcinoma and Palliative Treatment, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Terminated at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 2, Interventional, and Treatment
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
This is an open-label phase II, multicenter study. Eligible patients will receive SU011248 in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator (the median for treatment in renal cell study was 8 months).
Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow translational research with biopsies at crucial timing: at baseline before any treatment, , during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor or resistance.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 54 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
patients will receive SU011248 in monotherapy
Other: biopsies · Drug: SU011248
No intervention, only biopsy for translational project
no intervention
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Time frame: every 6 weeks
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Time frame: untill disaese progression
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Time frame: untill disease progression
Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
Time frame: at week 6 and at disaese progression after recist response
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain