metastatic or advanced solid tumors
Conditions
Interventions
radiolabeled nanatinostat: [14C]-Nanatinostat
Sponsors
Viracta Therapeutics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men or women that are at least 18 years of age at the time of informed consent. 2. Has histologically confirmed metastatic or advanced solid tumors refractory to standard therapy, and for whom no standard curative therapy exists. 3. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2. 4. Adequate laboratory parameters (in absence of transfusion support within three weeks or growth factor within two weeks of Screening), including: Absolute neutrophil count (ANC) >=1500/mm3 = 1.5 × 109/L. Platelets count >=90,000/mm3 = 90 × 109/L. Hemoglobin >=9.0 g/dL. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =60 mL/min by CKD-EPI equation. Serum potassium, magnesium, and corrected calcium outside normal limits for institution that are assessed as clinically significant by the Investigator should be treated to correct abnormalities with confirmation on repeat lab studies. 5. Life expectancy >3 months, as determined by the treating physician.
Exclusion criteria
Exclusion criteria: 1. Known history of central nervous system and/or leptomeningeal disease. 2. Prior treatment with [14C]-nanatinostat or history of allergic reactions attributed to compounds of similar chemical or biologic composition to [14C]-nanatinostat. 3. Inability to take or tolerate oral medication. 4. Any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. 5.Is currently participating in or has participated in an interventional study of an investigational agent or has used an investigational device within 4 weeks or 5 half-lives prior to dosing, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints • The amount of radioactivity excreted in urine and feces with an objective to recover >=90% of the radiolabeled nanatinostat. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • Concentration-time profile and PK parameters of total radioactivity from analysis of plasma, urine, and feces collected at identified timepoints. • PK parameter estimates for nanatinostat and metabolites M1 and M2 in plasma. • The amount of radioactivity in plasma and whole blood, including the erythrocyte transfer ratio (ETR) and erythrocyte/plasma partition coefficient (EPPC). • [14C]-metabolic profile and identification of metabolites in plasma and/or blood • Major radioactive peak/metabolites in the urine and fecal radiochromatograms as a percentage of the radioactive dose. • Incidence and severity of treatment-emergent adverse events (TEAEs). Adverse events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | — |
Countries
Netherlands
Outcome results
None listed