Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Adenoid Cystic Carcinoma
Interventions
DRUG

AG-013736 (AXITINIB)

All eligible patients will receive a starting axitinib dose of 5 mg twice daily (BID) taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above CTCAE v. 4.0 Grade 2 for a consecutive 2-week period may have their dose increased by one dose level according to the discretion of the treating physician (NOT allowed for patients with blood pressure (BP) \> 150/90 mm Hg or who are receiving antihypertensive medication). This dose escalation 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 (1)

10065

Memorial Sloan Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Comprehensive Cancer Network

NETWORK

collaborator

Pfizer

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01558661 - Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma | Biotech Hunter | Biotech Hunter