Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Solid Tumors
Interventions
DRUG

ME-344

"experimental drug, dose escalation with 5 planned dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8, and 15. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.~Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2 days each week. Cycle 1 at the highest dose level is 3 weekly IV infusions on days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal."

Trial Locations (3)

34232

Florida Cancer Specialists, Sarasota

73104

University of Oklahoma, Oklahoma City

Tennessee Oncology, PLLC, Nashville

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

SCRI Development Innovations, LLC

OTHER

lead

MEI Pharma, Inc.

INDUSTRY

NCT01544322 - Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors | Biotech Hunter | Biotech Hunter