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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4SC-202 | Drug | oral administration dose escalation twice daily (bid)or three times a day (tid) continuous dosing for 21 days per cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Dose Limiting Toxicities of 4SC-202 | 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. | 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 | 3 weeks |
| Determination of Maximum Tolerated Dose of 4SC-202 | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Histone deacetylase (HADAC) inhibition in peripheral mononuclear cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Engert, Prof. MD | Universitätsklinikum Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiätsklinikum Köln | Cologne | Germany | ||||
| Robert-Bosch-Krankenhaus |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000614036 | domatinostat |
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| 6 weeks |
| Histone acetylation in peripheral mononuclear cells | 6 weeks |
| Gene expression analysis in peripheral blood | 6 weeks |
| Cytokine and miRNA levels in plasma | 6 weeks |
| Stuttgart |
| Germany |
| Universitätsklinikum Würzburg | Würzburg | Germany |
| D007951 |
| Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |