Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors (ME-344-001)
The purpose of this study is to determine the tolerability of ME-344, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 as a Single Agent in Patients With Refractory Solid Tumors|
- Dose limiting toxicity [ Time Frame: One Cycle of 28 days ] [ Designated as safety issue: Yes ]Patients will be administered ME-344 IV infusions weekly for 3 weeks during the first 28 days cycle for dose limiting toxicity. Patients will be assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis, ECG, echocardiogram and pharmacokinetic sampling.
- Response Rate [ Time Frame: baseline and a minimum of every 12 weeks ] [ Designated as safety issue: No ]Radiologic assessments will be performed at baseline and a minimum of every 12 weeks. Patients may continue weekly dosing if there is clinical beneficial determined by the Investigator.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
- open label
- single agent
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.
|United States, Florida|
|Florida Cancer Specialists||Recruiting|
|Sarasota, Florida, United States, 34232|
|Contact: Jill Martin, RN 941-377-9993 ext 319 email@example.com|
|Principal Investigator: Manish R Patel, MD|
|United States, Oklahoma|
|University of Oklahoma||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Toni Davis, RN 405-271-8001 firstname.lastname@example.org|
|Principal Investigator: Kathleen Moore, MD|
|United States, Tennessee|
|Tennessee Oncology, PLLC||Recruiting|
|Nashville, Tennessee, United States, 73104|
|Contact: Marla Schider 615-339-4214 ASHSARAH@scresearch.net|
|Principal Investigator: Johanna C Bendell, SB, MD|
|Study Chair:||Robert D Mass, MD||MEI Pharma, Inc.|