An Investigation of the Mass Balance, Pharmacokinetics, Excretion and Metabolism of [14C]-Nanatinostat in Patients with Advanced Solid Tumors: A Phase 1, Open-Label Study
- Conditions
- metastatic or advanced solid tumors10027476
- Registration Number
- NL-OMON51840
- Lead Sponsor
- Viracta Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 6
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) <=2.5 × upper
limit of normal (ULN), or < 5x ULN in the presence of liver metastases.
Total bilirubin <=1.5 × ULN unless considered due to Gilbert*s syndrome, in
which case, <=3.0 × ULN.
Estimated glomerular filtration rate (eGFR) >=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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints<br /><br>• The amount of radioactivity excreted in urine and feces with an objective to<br /><br>recover >=90% of the radiolabeled nanatinostat.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>• Concentration-time profile and PK parameters of total radioactivity from<br /><br>analysis of plasma, urine, and feces collected at identified timepoints.<br /><br>• PK parameter estimates for nanatinostat and metabolites M1 and M2 in plasma.<br /><br>• The amount of radioactivity in plasma and whole blood, including the<br /><br>erythrocyte transfer ratio (ETR) and erythrocyte/plasma partition coefficient<br /><br>(EPPC).<br /><br>• [14C]-metabolic profile and identification of metabolites in plasma and/or<br /><br>blood<br /><br>• Major radioactive peak/metabolites in the urine and fecal radiochromatograms<br /><br>as a percentage of the radioactive dose.<br /><br>• Incidence and severity of treatment-emergent adverse events (TEAEs). Adverse<br /><br>events (AEs) will be graded according to National Cancer Institute (NCI) Common<br /><br>Terminology Criteria for Adverse Events (CTCAE), version 5.0.</p><br>