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

NCT06302140 | Terminated Phase 1 FDA Drug

• 1 other identifier: VT3996-102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (6)

• The amount of radioactivity in excreta [Part A]

  8 weeks after the last discharge visit in Part A

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

  8 weeks after the last discharge visit in Part B

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

  8 weeks after the last discharge visit in Part B

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

  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]

  8 weeks after the last discharge visit in Part B

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

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

Secondary Outcomes (18)

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

  Up to 7 days after the last discharge visit

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

  Up to 7 days after the last discharge visit

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

  8 weeks after the last discharge visit in Part A

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

  8 weeks after the last discharge visit in Part A

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

  8 weeks after the last discharge visit in Part A

Study Arms (4)

Part A: [14C]-Nanatinostat

EXPERIMENTAL

Drug: [14C]-Nanatinostat

Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir

EXPERIMENTAL

Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.

Drug: Nanatinostat (free base) tablets in combination with Valganciclovir

Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir

EXPERIMENTAL

Patients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours.

Drug: Nanatinostat mesylate tablets in combination with Valganciclovir

Part C: Single-agent Nanatinostat (free base) tablets

EXPERIMENTAL

Drug: Single-agent Nanatinostat (free base) tablets

Interventions

[14C]-Nanatinostat DRUG

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

Part A: [14C]-Nanatinostat

Nanatinostat (free base) tablets in combination with Valganciclovir DRUG

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

Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir

Nanatinostat mesylate tablets in combination with Valganciclovir DRUG

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

Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir

Single-agent Nanatinostat (free base) tablets DRUG

40 mg once daily under fed conditions until disease progression or unacceptable toxicity, whichever occurs first.

Part C: Single-agent Nanatinostat (free base) tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viracta Therapeutics, Inc.: lead

Study Sites (1)

START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Interventions

Tablets; Valganciclovir

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Darrel P Cohen, MD, PhD

  Viracta Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 8, 2024
• Study Start: February 28, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)