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

Advanced Cancer Clinical Trial

Official title:

A Phase 1 Study to Investigate the Mass Balance of [14C]-Nanatinostat and to Evaluate the Relative Bioavailability of Nanatinostat in Patients With Selected Advanced Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302140
• Other study ID #: VT3996-102
• Status: Recruiting
• Phase: Phase 1
• Start date: February 28, 2024
• Est. completion date: October 2025

Study information

• Verified date: March 2024
• Source: Viracta Therapeutics, Inc.
• Contact: Afton Katkov, MSc
• Phone: 858-400-8470
• Email: ClinicalTrials[@]Viracta.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: October 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• [14C]-Nanatinostat
A single oral dose administered on Day 1 in a fasted state.
• Nanatinostat (free base) tablets in combination with Valganciclovir
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 Valganciclovir
Treatment B: a single, oral dose of nanatinostat mesylate tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions.
• Single-agent Nanatinostat (free base) tablets
40 mg once daily under fed conditions until disease progression or unacceptable toxicity, whichever occurs first.

Locations

Country	Name	City	State
Spain	START Madrid - CIOCC - Hospital Universitario HM Sanchinarro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Viracta Therapeutics, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of radioactivity in excreta [Part A]		8 weeks after the last discharge visit in Part A
Primary	Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B]		8 weeks after the last discharge visit in Part B
Primary	Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B]		8 weeks after the last discharge visit in Part B
Primary	Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B]		8 weeks after the last discharge visit in Part B
Primary	Pharmacokinetic Parameter: Fraction of the administered dose in comparison with a standard (Frel) [Part B]		8 weeks after the last discharge visit in Part B
Primary	Incidence of adverse events and serious adverse events [Part C]		28 days after the last dose of study treatment in Part C
Secondary	Incidence of adverse events and serious adverse events [Parts A and B]		Up to 7 days after the last discharge visit
Secondary	Incidence of clinically significant changes in selected safety assessments [Parts A and B]		Up to 7 days after the last discharge visit
Secondary	Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A]		8 weeks after the last discharge visit in Part A
Secondary	The ratio of total radioactivity in blood relative to plasma [Part A]		8 weeks after the last discharge visit in Part A
Secondary	[14C]-metabolic profile and identification of metabolites in plasma [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A]		8 weeks after the last discharge visit in Part A
Secondary	Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B]		8 weeks after the last discharge visit in Part B
Secondary	Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B]		8 weeks after the last discharge visit in Part B
Secondary	Objective Response Rate (ORR) [Part C]		Approximately 1 year
Secondary	Time to Response (TTR) [Part C]		Approximately 1 year
Secondary	Duration of Response (DOR) [Part C]		Approximately 1 year
Secondary	Disease Control Rate (DCR) [Part C]		Approximately 1 year