The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.
Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Number of Adverse Events
The AE Profile will be determined by the number of AEs regardless of severity
Time frame: Through study completion- an average of 2 years
Number of Serious Adverse Events
The SAE Profile will be determined by the number of SAEs
Time frame: Through study completion- an average of 2 years
Maximum Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Time to Maximum Plasma Concentration for ME-344 (Tmax)
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Minimum Plasma Concentration (Cmin) of ME-344
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Mean Terminal Half-life (t 1/2)
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
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Oncology Hematology Care
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
University of WA Seattle Cancer Care Alliance
Seattle, Washington, United States
The Bays St Mary's Hospital
London, England, United Kingdom
Sarah Cannon Research Instititute UK
London, England, United Kingdom
Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.
Time frame: Response was assessed throughout the trial up to 13 months
Estimate the Overall Survival (OS)
41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.
Time frame: Up to 2 years