Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Advanced Cancer
Interventions
DRUG

Belinostat

"On Day 1, a single dose of 14C-labeled belinostat (approximately 94 to 105 µCi, 1500 mg) will be administered to the patient as a 30-minute IV infusion.~After Cycle 1 evaluations are completed, and if it is in the best interest of the patient, patients may receive additional cycles of non-radiolabeled belinostat until disease progression, unacceptable toxicity, or initiation of new anticancer therapy. After Cycle 1, Day 21, non radiolabeled belinostat will be administered IV as a 30 -45 minute infusion of 1000 mg/m2 on Days 1 through 5 every 21 days."

Trial Locations (1)

28050

Hospital Universitario Madrid Sanchinarro, Madrid

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY