The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
oral administration dose escalation twice daily (bid)or three times a day (tid) continuous dosing for 21 days per cycle
Universiätsklinikum Köln
Cologne, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Determination of Dose Limiting Toxicities of 4SC-202
Time frame: 6 weeks
Determination of Safety of 4SC-202
The safety and tolerability will be determined by occurrence of adverse events (AEs), vital signs (VS) \[body temperature, weight, blood pressure (BP), pulse rate\], electrocardiogram (ECG), performance status and clinical laboratory parameters.
Time frame: 6 weeks
Determination of Pharmacokinetic Profile of 4SC-202
The plasma concentrations of 4SC-202 will be determined at the following time-points: Cycle 1 Day 1: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. Cycle 1 Day 5: Pre-dose, 0.5 h, 1h, 2h Cycle 1 Day 14: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. Cycle 2 Day 1: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. using AUC0-infinity, AUClast, Cmax, tmax, t1/2, CL/F
Time frame: 3 weeks
Determination of Maximum Tolerated Dose of 4SC-202
Time frame: 6 weeks
Determination of Tolerability of 4SC-202
The safety and tolerability will be determined by occurrence of adverse events (AEs), vital signs (VS) \[body temperature, weight, blood pressure (BP), pulse rate\], electrocardiogram (ECG), performance status and clinical laboratory parameters.
Time frame: 6 weeks
Assessment of potential anticancer activity of 4SC-202
The assessment will be performed by assessment of tumor response, duration of response and progression free survival
Time frame: 6 weeks
Histone deacetylase (HADAC) inhibition in peripheral mononuclear cells
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 weeks
Histone acetylation in peripheral mononuclear cells
Time frame: 6 weeks
Gene expression analysis in peripheral blood
Time frame: 6 weeks
Cytokine and miRNA levels in plasma
Time frame: 6 weeks