This is a multicenter, nonrandomized, open-label, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing of Oratopo. No control group has been included.
This is a multicenter, open-label, safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumor malignancies. In the treatment period groups of 3 to 6 subjects will receive a single dose of oral Oratopo will be administered and will be followed for toxicity. Dose escalation will continue until an MTD is reached, or nonlinear increases in exposure are confirmed, or a maximum dose of Oratopo is reached.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets
HonorHealth Research Institute
Phoenix, Arizona, United States
Cancer Research UK Clinical Trials Unit- The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Sir Bobby Robson Cancer Trials Research Centre, Freeman Hospital
Newcastle, United Kingdom
Determination of Maximum Tolerated Dose (MTD)
dose limiting toxicities occuring in the first cycle of therapy
Time frame: Day 1 through 21
Safety assessment using Adverse Events of Oratopo
Safety assessment using Adverse Events of Oratopo
Time frame: Weekly, from randomization throughout the study for approximately 24 months
Pharmacokinetics of Oratopo
Plasma concentrations of Oratopo
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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