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Trial Title:
A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
NCT ID:
NCT06302140
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Valganciclovir
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
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.
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[14C]-Nanatinostat
Description:
A single oral dose administered on Day 1 in a fasted state.
Arm group label:
Part A: [14C]-Nanatinostat
Intervention type:
Drug
Intervention name:
Nanatinostat (free base) tablets in combination with Valganciclovir
Description:
Treatment A: a single, oral dose of nanatinostat (free base) tablets (20 mg) in
combination with valganciclovir (900 mg) under fed conditions.
Arm group label:
Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir
Intervention type:
Drug
Intervention name:
Nanatinostat mesylate tablets in combination with Valganciclovir
Description:
Treatment B: a single, oral dose of nanatinostat mesylate tablets (20 mg) in combination
with valganciclovir (900 mg) under fed conditions.
Arm group label:
Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir
Intervention type:
Drug
Intervention name:
Single-agent Nanatinostat (free base) tablets
Description:
40 mg once daily under fed conditions until disease progression or unacceptable toxicity,
whichever occurs first.
Arm group label:
Part C: Single-agent Nanatinostat (free base) tablets
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Contact:
Email:
ClinicalTrials@Viracta.com
Start date:
February 28, 2024
Completion date:
October 2025
Lead sponsor:
Agency:
Viracta Therapeutics, Inc.
Agency class:
Industry
Source:
Viracta Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302140
