Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

March 31, 2016

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Axitinib (AG-013736)

The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression (defined per RECIST \[Response Evaluation Criteria In Solid Tumors\] criteria, or obvious progression on clinical or laryngoscopic/endoscopic exam) or intolerable toxicity (defined as below). During treatment on this protocol, all patients will be evaluated for safety. Correlative biomarker analysis will also be conducted.

Trial Locations (1)

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

All Listed Sponsors
lead

University of Michigan Rogel Cancer Center

OTHER

NCT01469546 - Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer | Biotech Hunter | Biotech Hunter