Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Advanced Cancer
Interventions
DRUG

NPI-0052 on Days 1, 8, 15 every 28 days

NPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles

DRUG

NPI-0052 on Days 1, 4, 8, 11 every 21 days

NPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles

DRUG

Dexamethasone

20 mg oral or IV day before and day after NPI-0052 dosing.

Trial Locations (7)

3002

Peter MacCallum Cancen Center, Melbourne

3168

The Alfred Hospital, Melbourne

3690

Border Medical Oncology, Wodonga

4101

Mater Adult Hospital, South Brisbane

5001

The Queen Elizabeth Hospital, Woodville South

6001

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital and University of Western Australia, Nedlands

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY