A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers

Phase 1TerminatedNCT06302140

Viracta Therapeutics, Inc.8 enrolled

Overview

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.

This is a Phase 1, open-label, 3-part study evaluating the mass balance, pharmacokinetics, and metabolism of nanatinostat following a single oral dose of \[14C\]-nanatinostat for Part A, evaluating relative bioavailability of nanatinostat mesylate and nanatinostat (free base) tablets after coadministration with valganciclovir in patients with advanced stage cancers for Part B, and evaluating the safety and antitumor activity of nanatinostat for Part C. The study was terminated prematurely and did not reach its target enrollment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Advanced Cancer

Interventions

[14C]-NanatinostatDRUG

A single oral dose administered on Day 1 in a fasted state.

Nanatinostat (free base) tablets in combination with ValganciclovirDRUG

Treatment A: a single, oral dose of nanatinostat (free base) tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions.

Nanatinostat mesylate tablets in combination with ValganciclovirDRUG

Treatment B: a single, oral dose of nanatinostat mesylate tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Have histologically confirmed advanced stage cancers (excluding gastrointestinal tumors), have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment, and have no available treatment with curative intent. * Eastern Cooperative Oncology Group Performance Status of ≤2 at Screening. * Body mass index ≥18.5 but ≤30.0 kg/m2 at Screening. * Adequate bone marrow, liver, and kidney function. Key Exclusion Criteria: * Presence of active central nervous system and/or leptomeningeal disease. * Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or use of other investigational agents within 4 weeks before study entry. * Inability to take or tolerate oral medication. * Any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. * Active infection requiring systemic therapy. * Has received radiolabeled material \<12 months (excluding that required for imaging) prior to study entry.

Locations (1)

START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

Madrid, Spain

Outcomes

Primary Outcomes

The amount of radioactivity in excreta [Part A]

Time frame: 8 weeks after the last discharge visit in Part A

Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B]

Time frame: 8 weeks after the last discharge visit in Part B

Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B]

Time frame: 8 weeks after the last discharge visit in Part B

Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B]

Time frame: 8 weeks after the last discharge visit in Part B

Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B]

Time frame: 8 weeks after the last discharge visit in Part B

Incidence of adverse events and serious adverse events [Part C]

Time frame: 28 days after the last dose of study treatment in Part C

Secondary Outcomes

Incidence of adverse events and serious adverse events [Parts A and B]

Time frame: Up to 7 days after the last discharge visit

Incidence of clinically significant changes in selected safety assessments [Parts A and B]

Time frame: Up to 7 days after the last discharge visit

Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A]

Time frame: 8 weeks after the last discharge visit in Part A

Data from ClinicalTrials.gov

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