protocolSection identificationModule nctId: NCT06302140, orgStudyIdInfo id: VT3996-102, briefTitle: A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Viracta Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers., conditionsModule conditions: Advanced Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This clinical trial is divided into 3 parts (Part A, Part B, and Part C).Patients may begin their study participation in Part A or Part B. Part B (for patients who participate in Part A) and Part C (for patients who participate in Part A and/or Part B) are optional for patients who meet certain conditions for crossover.In Part A, patients will be given a single dose of radiolabeled nanatinostat by mouth on Day 1. Patients may stay in the hospital up to 8 days.In Part B, patients will receive both nanatinostat in a salt form and a non-salt form, coadministered with valganciclovir in different order across 2 treatment days. Patients will be randomly assigned to either receive the salt or the non-salt form of nanatinostat first. Patients may stay in the hospital up to 4 days.Part C will allow patients to continue receiving nanatinostat treatment as long as they are deriving clinical benefit. This part will not require a hospital stay., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-Nanatinostat, interventions name: Nanatinostat (free base) tablets in combination with Valganciclovir, interventions name: Nanatinostat mesylate tablets in combination with Valganciclovir, interventions name: Single-agent Nanatinostat (free base) tablets, outcomesModule primaryOutcomes measure: The amount of radioactivity in excreta [Part A], primaryOutcomes measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B], primaryOutcomes measure: Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B], primaryOutcomes measure: Incidence of adverse events and serious adverse events [Part C], secondaryOutcomes measure: Incidence of adverse events and serious adverse events [Parts A and B], secondaryOutcomes measure: Incidence of clinically significant changes in selected safety assessments [Parts A and B], secondaryOutcomes measure: Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A], secondaryOutcomes measure: The ratio of total radioactivity in blood relative to plasma [Part A], secondaryOutcomes measure: [14C]-metabolic profile and identification of metabolites in plasma [Part A], secondaryOutcomes measure: Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A], secondaryOutcomes measure: Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B], secondaryOutcomes measure: Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B], secondaryOutcomes measure: Objective Response Rate (ORR) [Part C], secondaryOutcomes measure: Time to Response (TTR) [Part C], secondaryOutcomes measure: Duration of Response (DOR) [Part C], secondaryOutcomes measure: Disease Control Rate (DCR) [Part C], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Madrid - CIOCC - Hospital Universitario HM Sanchinarro, status: RECRUITING, city: Madrid, zip: 28050, country: Spain, contacts role: CONTACT, email: ClinicalTrials@Viracta.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False