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

Study Identifier:
VT3996-102
CT.gov Identifier:
NCT06302140
EudraCT Identifier:
202350818474
EU Trial (CTIS) Number:
2023-508184-74-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unspecified Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Part A
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Drug: Experimental: Part B (Treatment A)
Drug: Experimental: Part B (Treatment B)
Drug: Experimental: Part C
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • Key
  • - 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Emiliano Calvo
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Unspecified Cancer