NCT01463046 - Phase I Dose Finding and Proof-of-concept Study of Panobinostat With Standard Dose Cytarabine and Daunorubicin for Untreated Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 14, 2015

Study Completion Date

December 31, 2018

Conditions

Acute Myeloid LeukemiaAdvanced Myelodysplastic Syndrome

Interventions

DRUG

Panobinostat

"Induction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8~Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5~Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8"

DRUG

Cytarabine

"Induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.~Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7.~Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9."

DRUG

Daunorubicin

"Induction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.~Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4.~Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5."

Trial Locations (1)

94143

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco