Advanced CancerPhase 1NCT06302140
A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers
A Phase 1 study testing [14C]-Nanatinostat, Nanatinostat (free base) tablets in combination with Valganciclovir and Nanatinostat mesylate tablets in combination with Valganciclovir in people with Advanced Cancer, run by Viracta Therapeutics, Inc. at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- [14C]-Nanatinostat, Nanatinostat (free base) tablets in combination with Valganciclovir and Nanatinostat mesylate tablets in combination with Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2024to 15 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
START Madrid - CIOCC - Hospital Universitario HM Sanchinarro
Madrid, 28050
About this study
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
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.
Read the 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.
The study was terminated prematurely and did not reach its target enrollment.
- Conditions
- Advanced Cancer
- Being tested
- [14C]-Nanatinostat, Nanatinostat (free base) tablets in combination with Valganciclovir, Nanatinostat mesylate tablets in combination with Valganciclovir, Single-agent Nanatinostat (free base) tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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.
Single-agent Nanatinostat (free base) tabletsDrug
40 mg once daily under fed conditions until disease progression or unacceptable toxicity, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Part A: [14C]-Nanatinostat | Experimental | Not described Receives: 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. Receives: 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. Receives: Drug: Nanatinostat mesylate tablets in combination with Valganciclovir |
| Part C: Single-agent Nanatinostat (free base) tablets | Experimental | Not described Receives: Drug: Single-agent Nanatinostat (free base) tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of radioactivity in excreta [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part B]
Measured: 8 weeks after the last discharge visit in Part B
Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part B]
Measured: 8 weeks after the last discharge visit in Part B
Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part B]
Measured: 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]
Measured: 8 weeks after the last discharge visit in Part B
Incidence of adverse events and serious adverse events [Part C]
Measured: 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]
Measured: Up to 7 days after the last discharge visit
Incidence of clinically significant changes in selected safety assessments [Parts A and B]
Measured: Up to 7 days after the last discharge visit
Pharmacokinetic Parameter: area under the plasma concentration versus time curve (AUC) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A]
Measured: 8 weeks after the last discharge visit in Part A
The ratio of total radioactivity in blood relative to plasma [Part A]
Measured: 8 weeks after the last discharge visit in Part A
[14C]-metabolic profile and identification of metabolites in plasma [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A]
Measured: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B]
Measured: 8 weeks after the last discharge visit in Part B
Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B]
Measured: 8 weeks after the last discharge visit in Part B
Objective Response Rate (ORR) [Part C]
Measured: Approximately 1 year
Time to Response (TTR) [Part C]
Measured: Approximately 1 year
Duration of Response (DOR) [Part C]
Measured: Approximately 1 year
Disease Control Rate (DCR) [Part C]
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start28 Feb 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viracta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darrel P Cohen, MD, PhD, Study director, Viracta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302140
- Sponsor's protocol ID
- VT3996-102
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06302140
- Acronym / sponsor ID
- VT3996-102
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Viracta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study was terminated prematurely and did not reach its target enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A: [14C]-Nanatinostat | Experimental | Drug: [14C]-Nanatinostat |
| Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir | Experimental | Drug: Nanatinostat (free base) tablets in combination with ValganciclovirPatients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours. |
| Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir | Experimental | Drug: Nanatinostat mesylate tablets in combination with ValganciclovirPatients will be randomized into 2 treatment sequences (AB and BA) in Periods 1 and 2. Each treatment period is 24 hours. |
| Part C: Single-agent Nanatinostat (free base) tablets | Experimental | Drug: Single-agent Nanatinostat (free base) tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-NanatinostatA single oral dose administered on Day 1 in a fasted state. | Drug | Part A: [14C]-Nanatinostat |
| Nanatinostat (free base) tablets in combination with ValganciclovirTreatment A: a single, oral dose of nanatinostat (free base) tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions. | Drug | Part B (Treatment A): Nanatinostat (free base) tablets in combination with Valganciclovir |
| Nanatinostat mesylate tablets in combination with ValganciclovirTreatment B: a single, oral dose of nanatinostat mesylate tablets (20 mg) in combination with valganciclovir (900 mg) under fed conditions. | Drug | Part B (Treatment B): Nanatinostat mesylate tablets in combination with Valganciclovir |
| Single-agent Nanatinostat (free base) tablets40 mg once daily under fed conditions until disease progression or unacceptable toxicity, whichever occurs first. | Drug | Part C: Single-agent Nanatinostat (free base) tablets |
Primary outcome
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
18 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
Pharmacokinetic Parameter: maximum plasma concentration (Cmax) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: time to maximum observed plasma concentration (Tmax) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination half-life (t1/2) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: apparent total clearance (CL/F) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: apparent volume of distribution during terminal phase (Vz/F) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination rate constant from the central compartment (Kel) [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
The ratio of total radioactivity in blood relative to plasma [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
[14C]-metabolic profile and identification of metabolites in plasma [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Major radioactive peak/metabolites in urine and fecal radiochromatograms as a percentage of the radioactive dose [Part A]
Time frame: 8 weeks after the last discharge visit in Part A
Pharmacokinetic Parameter: elimination half-life (t1/2) [Part B]
Time frame: 8 weeks after the last discharge visit in Part B
Pharmacokinetic Parameter: metabolite-to-parent ratio [Part B]
Time frame: 8 weeks after the last discharge visit in Part B
Objective Response Rate (ORR) [Part C]
Time frame: Approximately 1 year
Time to Response (TTR) [Part C]
Time frame: Approximately 1 year
Duration of Response (DOR) [Part C]
Time frame: Approximately 1 year
Disease Control Rate (DCR) [Part C]
Time frame: Approximately 1 year
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrel P Cohen, MD, PhD study director
Viracta Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-Nanatinostat, Nanatinostat (free base) tablets in combination with Valganciclovir and Nanatinostat mesylate tablets in combination with Valganciclovir in people with Advanced Cancer, run by Viracta Therapeutics, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of radioactivity in excreta [Part A] (time frame: 8 weeks after the last discharge visit in Part A). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.