Regorafenib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

November 7, 2024

Study Completion Date

November 7, 2024

Conditions
Adenoid Cystic Carcinoma
Interventions
DRUG

Regorafenib

All eligible patients will receive a starting regorafenib dose of 120 mg daily taken orally for 3 weeks in a 4-week cycle. Patients for whom regorafenib dose reduction was not performed or required may have their treatment dose increased to the FDA-approved dose of 160 mg daily orally for 3 weeks in a 4-week cycle in cycle #2 or beyond (this is not mandatory). RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity

Trial Locations (5)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11725

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack

Unknown

Memorial Sloan Kettering Cancer Center, Basking Ridge

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER